sssohrab/ct-dosing-errors-benchmark · Datasets at Hugging Face

[ 4 ]

102

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulate more photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon illumination. For skin diseases, there has been an increasing interest in using precursors of the endogenous photoactive porphyrins. The most commonly used precursors have been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix®, contains the methyl ester of ALA, which penetrates the lesions well and shows high lesion selectivity . BCC is a highly frequent skin malignancy, and accounts for approximately 75% of all non-melanoma skin cancers. It is the most common cancer in humans. Several non-pharmacological treatment modalities are used for BCC, including excision surgery, curettage and electrodesiccation, cryosurgery and more advanced modalities like radiation therapy, plastic surgery with reconstruction and Moh's surgery. The treatment used depends on the type, size, depth and localisation of the BCC lesion. Treatment options for BCC give good response rates in the majority of participants but are inadequate in a small group of participants defined as "high-risk" BCC. In this particular participant group, even a moderate complete response rate with good cosmetic results may be considered beneficial, since the number of participant who have to receive more advanced therapy with the possibility of high morbidity and poor cosmetic outcome was reduced. Even a partial response is of clinical interest since the remaining tumour was require less extensive surgery. In the case of treatment failure, Metvix PDT does not interfere with the use of other treatment modalities. The variable "complete response" after one or two Metvix treatment cycles was used as the basis for the justification of sample size.

Prospective, open, multicenter study. The high risk BCC lesions were treated with Metvix cream. A biopsy confirming the diagnosis of each BCC lesion should have been taken within 6 months prior to treatment. The participants was receive one or two treatment cycles each consisting of two Metvix PDT treatments 7 days apart (Lesions that did not respond completely after three months received a second PDT treatment cycle). The primary end-point was the histologically confirmed complete response rate within a participant (No BCC cells in the biopsy taken 3 months after the last treatment).

Basal Cell Carcinoma

Photodynamic therapy (PDT) PDT with Metvix cream "High risk" BCC Basal Cell carcinoma Histologically confirmed complete response

null

1

arm 1: Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm\*2) up to 13 weeks.

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Metvix® cream

7

0

NCT00473343

[ 4 ]

297

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving pain due to Diabetic Neuropathy.

This was a 15 week (one week baseline and fourteen weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex in subjects with pain due to diabetic neuropathy. Subjects were screened to determine eligibility and completed a seven-day baseline period. Subjects then returned to the centre for assessment, randomisation and dose introduction. Visits occurred at the end of weeks two, six, ten and at the end of the study (treatment week 14) or earlier if they withdrew. A follow up visit occurred 28 days after completion or withdrawal. Subjects in this study were given the opportunity to be enrolled in an open label extension study.

Pain Diabetic Neuropathy

Pain diabetic neuropathy

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours intervention 2: containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.

intervention 1: Sativex intervention 2: Placebo

1

Sheffield | Yorkshire | United Kingdom | -1.4659 | 53.38297

0

NCT00710424

[ 2 ]

9

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

* DermaVir is a plasmid DNA-containing synthetic nanomedicine. It is administered topically with DermaPrep to target Langerhans cells. Langerhans cells with DermaVir migrate to lymph nodes and express HIV-like particles that induce immune responses to kill HIV-infected cells. * Hypothesis: Single DermaVir immunization is safe and immunogenic measured by induction of HIV-specific precursor/memory T cell responses. * GIHU004 was a phase I dose escalation study conducted in Hungary. It evaluated the safety and immunogenicity of three dosing regimens of topical DermaVir immunization for the treatment of HIV-infected individuals on fully suppressive highly active antiretroviral therapy (HAART).

This study enrolled nine HIV-infected adult subjects in three sequential dose cohorts. All had durable suppression of HIV-RNA on HAART over the previous 6 months and CD4 count over 300 cells/mm3. Subjects, received on study Day 0 a single DermaVir immunization: * Low dose: 0.1 mg pDNA, 0.8 mL DermaVir administered under two DermaPrep patches. * Medium dose: 0.4 mg pDNA, 3.2 mL DermaVir administered under four DermaPrep patches. * High dose: 0.8 mg pDNA, 6.4 mL DermaVir administered under eight DermaPrep patches. Subjects were on study for a total of 28 days followed by a post-treatment safety follow-up for 48 weeks. HAART was not interrupted. All subjects completed the 28-day treatment and 48 weeks safety follow up phase.

HIV Infection

HIV Vaccine Immune Therapy DermaVir

null

3

arm 1: Single low-dose DermaVir immunization * 0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir * Administered topically with DermaPrep under two skin patches (0.4 mL/patch) arm 2: Single medium-dose DermaVir immunization * 0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir * Administered topically with DermaPrep under four skin patches (0.8 mL/patch) arm 3: Single high-dose DermaVir immunization * 0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir * Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)

[ 0, 0, 0 ]

2

[ 2, 0 ]

intervention 1: DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a plasmid DNA expressing fifteen HIV proteins that assemble into HIV-like particles. These particles are safe, cannot replicate, integrate or reverse transcribed. DermaVir is targeted to Langerhans cells with DermaPrep medical device. These DermaVir-containing Langerhans cells migrate to the lymph nodes, where induce HIV-specific cytotoxic T cells that can recognize and kill HIV-infected cells. intervention 2: Three or more antiretroviral drugs that can fully suppress HIV RNA

intervention 1: DermaVir intervention 2: HAART

1

Budapest | Budapest | Hungary | 19.04045 | 47.49835

0

NCT00712530

[ 2 ]

12

NON_RANDOMIZED

SINGLE_GROUP

7BASIC_SCIENCE

0NONE

false

0ALL

false

This study was designed to estimate the effects of methotrexate (MTX) on the pharmacokinetics (PK) of CP-690,550 when administered to subjects with rheumatoid arthritis (RA), to estimate the effects of CP-690,550 on the PK of MTX and to evaluate the short-term safety and tolerability of co-administration of CP-690,550 and MTX.

null

Rheumatoid Arthritis

Pharmacokinetics oral JAK inhibitor methotrexate (MTX) rheumatoid arthritis (RA)

null

1

arm 1: Individual dose of methotrexate with the addition of CP-690,550 30 mg q12h

[ 0 ]

2

[ 0, 0 ]

intervention 1: CP-690,550 30 mg q12h for 5 days intervention 2: individual dose of methotrexate (stably dosed)

intervention 1: CP-690,550 (tofacitinib) intervention 2: Methotrexate (MTX)

4

0

NCT01745055

[ 2 ]

40

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

false

Open-label, single-dose (BIA 2-093 800 mg tablet), single-centre study in five groups of subjects with various degrees of renal function based on creatinine clearance

This was an open-label, single-dose (BIA 2-093 800 mg tablet), single-centre study in five groups of subjects with various degrees of renal function based on creatinine clearance (stages of renal function according to the Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products Guidelines) for the evaluation of pharmacokinetics in patients with impaired renal function. The trial commenced with Groups 1 and 2. An interim safety evaluation was conducted and, as there were no safety concerns, the trial continued with Groups 3 and 4. After another interim safety evaluation with the data from Groups 3 and 4, the trial commenced with Group 5.

Epilepsy

null

5

arm 1: normal renal function (creatinine clearance \> 80 mL/min) arm 2: mild renal impairment (creatinine clearance 50-80 mL/min) arm 3: moderate renal impairment (creatinine clearance 30-50 mL/min) arm 4: severe renal impairment (creatinine clearance \<30 mL/min) arm 5: end stage renal disease, requiring haemodialysis (ESRD)

[ 5, 5, 5, 5, 5 ]

1

[ 0 ]

intervention 1: None

intervention 1: BIA 2-093

1

Bloemfontein | Bloemfontein | South Africa | 26.214 | -29.12107

0

NCT02281422

[ 4 ]

94

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is: * to explore the dose-response relation of sugammadex (Org 25969, MK-8616, SCH 900616) given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult participants * to explore the pharmacokinetics (PK) of sugammadex in pediatric and adult participants, and to evaluate the safety of sugammadex in pediatric and adult participants.

null

Anesthesia

null

5

arm 1: Participants are to receive an intravenous (IV) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex is to be given. arm 2: Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex is to be given. arm 3: Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex is to be given. arm 4: Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex is to be given. arm 5: Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single 3-mL bolus dose of placebo (sodium chloride 0.9% solution) is to be given.

[ 0, 0, 0, 0, 2 ]

6

[ 0, 0, 0, 0, 0, 0 ]

intervention 1: IV infusion intervention 2: IV infusion intervention 3: IV infusion intervention 4: IV infusion intervention 5: IV infusion intervention 6: IV infusion

intervention 1: Sugammadex 0.5 mg/kg intervention 2: Sugammadex 1 mg/kg intervention 3: Sugammadex 2 mg/kg intervention 4: Sugammadex 4 mg/kg intervention 5: Placebo intervention 6: Rocuronium bromide

0

null

0

NCT00421148

[ 3 ]

30

RANDOMIZED

PARALLEL

0TREATMENT

null

false

0ALL

null

To investigate the preliminary pharmacokinetics, pharmacodynamics, safety and tolerability of GW823093 at doses of 15mg and 30mg given once daily for 7 days in Japanese Type 2 diabetes mellitus (T2DM) patients.

null

Diabetes Mellitus, Type 2

pharmacodynamics Diabetes pharmacokinetics

null

3

arm 1: Participants received two capsules of matching placebo orally once daily in the morning with 150 milliliter (mL) of water at least 15 minutes prior to breakfast for 7 Days. arm 2: Participants received one 15 milligrams (mg) of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days. arm 3: Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.

[ 2, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: White opaque capsule containing 15mg of GW823093 as free base intervention 2: Matching placebo of GW823093 capsule or 15mg capsule intervention 3: White opaque capsule containing 15mg of GW823093 as free base

intervention 1: GW823093 15mg intervention 2: GW823093 placebo capsule intervention 3: GW823093 30mg

1

N/A | N/A | N/A | N/A | N/A

0

NCT00372957

[ 3 ]

210

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.

null

Epilepsy

Epilepsy: partial onset seizures brivaracetam

null

4

arm 1: Matching Placebo tablets administered twice a day arm 2: Brivaracetam 5 mg/day, 2.5 mg administered twice a day arm 3: Brivaracetam 20 mg/day, 10 mg administered twice a day arm 4: Brivaracetam 50 mg/day, 25 mg administered twice a day

[ 2, 0, 0, 0 ]

2

[ 10, 0 ]

intervention 1: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period intervention 2: Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period

intervention 1: Placebo intervention 2: Brivaracetam

42

0

NCT00175825

[ 4 ]

97

RANDOMIZED

CROSSOVER

0TREATMENT

1SINGLE

false

0ALL

null

The Protocol section needs to be updated using the following text "The main goal of the study was to validate the Preference Module of the EARNS-Q and to test the reliability using Treatment Satisfaction Questionnaire for Medicines (TSQM), a validated questionnaire for determining satisfaction among different treatment. The EARNS-Q is divided into 2 modules, an Experience Module and a Preference Module. The Experience Module includes 28 items, fourteen attribute rating items followed by fourteen importance weighing questions. The Preference Module includes the same items along with preference questions related to each item as well as a global preference question.

null

Rhinitis, Allergic, Perennial

questionnaire nasal spray Seasonal allergic rhinitis nasal spray questionnaire allergic rhinitis

null

0

null

2

[ 0, 0 ]

intervention 1: Beclomethasone dipropionate intervention 2: Flunisolide

7

0

NCT00346775

[ 5 ]

96

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The overall objective of the study is to develop recommendations for treatment programs to help alcoholic smokers to stop smoking. A sample of 175 alcohol dependent cigarette smokers will be recruited from the community and treated in a 6-month outpatient alcohol and tobacco treatment program. The 175 patients will be divided into two groups. One group will receive an active nicotine patch and active nicotine gum. The other group will receive an active nicotine patch and placebo nicotine gum. Followup assessments will be conducted for 1-year from the beginning of treatment.

null

Smoking Alcoholism

null

2

arm 1: Subjects in both arms were instructed to use one 21-mg (Nicoderm CQ®) nicotine patch daily for 8 weeks followed by one 14-mg patch daily for 2 weeks, then followed by one 7-mg patch daily for 2 weeks, for a total of 12 weeks of nicotine patch therapy. Placebo gum was given for ad libitum use, with encouragement to use at least six pieces per day, up to a maximum of 20 pieces per day. The placebo gum (manufactured by Fertin Pharma A/S, Vejle, Denmark) contained 2.6% cayenne pepper to simulate the taste of nicotine. Use of the gum was encouraged for 24 weeks. arm 2: Subjects in both arms were instructed to use one 21-mg (Nicoderm CQ®) nicotine patch daily for 8 weeks followed by one 14-mg patch daily for 2 weeks, then followed by one 7-mg patch daily for 2 weeks, for a total of 12 weeks of nicotine patch therapy. Nicotine gum (2 mg uncoated mint Nicorette®) was given for ad libitum use, with encouragement to use at least six pieces per day, up to a maximum of 20 pieces per day. Use of the gum was encouraged for 24 weeks.

[ 2, 1 ]

4

[ 5, 0, 0, 0 ]

intervention 1: Individual 60-minute treatment sessions were scheduled weekly for the first 3 months, then monthly for the next 3 months for a total of 16 sessions. Alcohol treatment was based on the cognitive behavioral therapy manual developed for Project MATCH, with approximately 40-45 minutes of each session devoted to alcohol treatment. Components of this intervention included identifying alcohol antecedents, coping with alcohol urges, managing thoughts about alcohol, problem solving, drink refusal skills, planning for emergencies, communication and assertiveness training and enhancing social support networks for alcohol abstinence. The smoking cessation intervention was delivered in the same sessions as the alcohol treatment, with approximately 15-20 minutes of each session devoted to smoking cessation. Treatment employed behavioral elements that have been supported empirically according to the USDHHS smoking cessation practice guideline. intervention 2: Subjects in both arms were instructed to use one 21-mg (Nicoderm CQ®) nicotine patch daily for 8 weeks followed by one 14-mg patch daily for 2 weeks, then followed by one 7-mg patch daily for 2 weeks, for a total of 12 weeks of nicotine patch therapy. intervention 3: Placebo gum was given for ad libitum use, with encouragement to use at least six pieces per day, up to a maximum of 20 pieces per day. The placebo gum (manufactured by Fertin Pharma A/S, Vejle, Denmark) contained 2.6% cayenne pepper to simulate the taste of nicotine. Use of the gum was encouraged for 24 weeks. intervention 4: Nicotine gum (2 mg uncoated mint Nicorette®) was given for ad libitum use, with encouragement to use at least six pieces per day, up to a maximum of 20 pieces per day. Use of the gum was encouraged for 24 weeks.

intervention 1: Cognitive Behavior Therapy for alcohol and smoking cessation intervention 2: Nicoderm CQ nicotine patch intervention 3: Placebo gum intervention 4: Nicotine gum - Nicorette®

1

Newington | Connecticut | United States | -72.72371 | 41.69788

0

NCT00064844

[ 4 ]

328

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure \[nCPAP\] therapy), or chronic shift work sleep disorder (SWSD).

null

Narcolepsy Sleep Apnea, Obstructive Sleep Apnea Syndromes Shift-Work Sleep Disorder

Excessive Sleepiness Narcolepsy Cataplexy Sleep Attacks Obstructive Sleep Apnea Obstructive Sleep Hypopnea nCPAP Chronic Shift Work Sleep Disorder Chronic SWSD Circadian Rhythm Disorder Shift Worker Cepahlon Cephalon, Inc Nuvigil

null

0

null

1

[ 0 ]

intervention 1: Armodafinil (po) 100 to 250 mg/day up to 12 months

intervention 1: CEP-10953 (Armodafinil)

50

0

NCT00078312

[ 4 ]

91

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to determine the safety and tolerability of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic Renal Insufficiency (inadequate kidney function).

null

Diabetes Mellitus, Type 2 Chronic Renal Insufficiency

Type 2 Diabetes Mellitus and Chronic Renal Insufficiency

null

2

arm 1: Participants in the Sitagliptin treatment sequence will receive sitagliptin in Phase A and placebo to glipizide in Phase B. arm 2: Participants in the Placebo treatment sequence will receive placebo to sitagliptin in Phase A and glipizide in Phase B.

[ 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: One (participants with visit 1 estimated creatinine clearance \<30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to \<50 mL/min; not on dialysis) tablets of 25 mg Sitagliptin daily. intervention 2: One (participants with visit 1 estimated creatinine clearance \<30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to \<50 mL/min and not on dialysis) tablets of placebo to sitagliptin 25 mg daily. intervention 3: One 5 mg glipizide tablet per day. The dose of glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations. intervention 4: One placebo to glipizide 5 mg tablet per day. The dose of placebo to glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.

intervention 1: sitagliptin intervention 2: Placebo to Sitagliptin intervention 3: glipizide intervention 4: Placebo to glipizide

0

null

0

NCT00095056

[ 3 ]

61

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

0ALL

true

This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant patients. Stage 1 was to randomize approximately 54 subjects. After all Stage 1 subjects had completed 6 months of treatment, Stage 2 was to randomize an additional 195 subjects to the same treatment groups.

null

Kidney Transplantation

tofacitinib CP-690550 kidney transplant

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 15 mg twice daily intervention 2: 30 mg twice daily intervention 3: dose adjusted according to level

intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: tacrolimus

20

0

NCT00106639

[ 4 ]

3,494

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

null

The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

null

Thromboembolism Arthroplasty, Replacement, Hip

null

3

arm 1: daily dose 150 mg once daily, half a dose on the day of surgery arm 2: daily dose 220 mg once daily, half a dose on the day of surgery arm 3: 40 mg once daily

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: daily dose 150 mg once daily, half a dose on the day of surgery intervention 2: daily dose 150 mg once daily, half a dose on the day of surgery intervention 3: 40 mg once daily

intervention 1: dabigatran etexilate intervention 2: dabigatran etexilate intervention 3: enoxaparin

116

Garren | Australian Capital Territory | Australia | N/A | N/A Kogarah | New South Wales | Australia | 151.13564 | -33.9681 Lismore | New South Wales | Australia | 153.2773 | -28.81354 Bedford Park | South Australia | Australia | 138.56815 | -35.02204 Box Hill | Victoria | Australia | 145.12545 | -37.81887 Clayton | Victoria | Australia | 145.11667 | -37.91667 Malvern | Victoria | Australia | 145.02811 | -37.86259 Ringwood East | Victoria | Australia | 145.25 | -37.81667 Windsor | Victoria | Australia | 144.99241 | -37.85344 Perth | Western Australia | Australia | 115.8614 | -31.95224 Linz | N/A | Austria | 14.28611 | 48.30639 Vienna | N/A | Austria | 16.37208 | 48.20849 Wels | N/A | Austria | 14.03333 | 48.16667 Wiener Neustadt | N/A | Austria | 16.23196 | 47.80485 Brussels | N/A | Belgium | 4.34878 | 50.85045 Ghent | N/A | Belgium | 3.71667 | 51.05 Ghent | N/A | Belgium | 3.71667 | 51.05 Hasselt | N/A | Belgium | 5.33781 | 50.93106 Herentals | N/A | Belgium | 4.83248 | 51.17655 Lanaken | N/A | Belgium | 5.6468 | 50.89318 Leuven | N/A | Belgium | 4.70093 | 50.87959 Brno-Bohunice | N/A | Czechia | N/A | N/A Chomutov | N/A | Czechia | 13.41779 | 50.46048 Havlíčkův Brod | N/A | Czechia | 15.57937 | 49.6069 Jihlava | N/A | Czechia | 15.59124 | 49.3961 Kladno | N/A | Czechia | 14.10285 | 50.14734 Kolín | N/A | Czechia | 15.1998 | 50.02806 Ostrava | N/A | Czechia | 18.28204 | 49.83465 Pilsen | N/A | Czechia | 13.37759 | 49.74747 Pradubice | N/A | Czechia | N/A | N/A Prague | N/A | Czechia | 14.42076 | 50.08804 Hellerup | N/A | Denmark | 12.57093 | 55.73204 Hørsholm | N/A | Denmark | 12.50111 | 55.88098 København NV | N/A | Denmark | 12.52343 | 55.71258 København S | N/A | Denmark | 12.5978 | 55.65059 Silkeborg | N/A | Denmark | 9.54508 | 56.1697 Helsinki | N/A | Finland | 24.93545 | 60.16952 Jyväskylä | N/A | Finland | 25.72088 | 62.24147 Oulu | N/A | Finland | 25.46816 | 65.01236 Seinäjoki | N/A | Finland | 22.82822 | 62.79446 Tampere | N/A | Finland | 23.78712 | 61.49911 Amiens | N/A | France | 2.3 | 49.9 Roubaix | N/A | France | 3.17456 | 50.69421 Soyaux | N/A | France | 0.19752 | 45.64052 Strasbourg | N/A | France | 7.74553 | 48.58392 Bad Mergentheim | N/A | Germany | 9.77361 | 49.4925 Erlangen | N/A | Germany | 11.00783 | 49.59099 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Garmisch-Partenkirchen | N/A | Germany | 11.09576 | 47.49209 Kamp-Lintfort | N/A | Germany | 6.54587 | 51.50467 Mainz | N/A | Germany | 8.2791 | 49.98419 Markgröningen | N/A | Germany | 9.08059 | 48.90493 Rheinfelden | N/A | Germany | 7.78715 | 47.56013 Schwandorf in Bayern | N/A | Germany | 12.1098 | 49.32534 Sommerfeld | N/A | Germany | 13.0014 | 54.36652 Wiesbaden | N/A | Germany | 8.24932 | 50.08258 Békéscsaba | N/A | Hungary | 21.1 | 46.68333 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Gyula | N/A | Hungary | 21.28333 | 46.65 Kecskemét | N/A | Hungary | 19.69128 | 46.90618 Szeged | N/A | Hungary | 20.14824 | 46.253 Székesfehérvár | N/A | Hungary | 18.41034 | 47.18995 Bergamo | N/A | Italy | 9.66721 | 45.69601 Bologna | N/A | Italy | 11.33875 | 44.49381 Milan | N/A | Italy | 12.59836 | 42.78235 Pavia | N/A | Italy | 9.15917 | 45.19205 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Heemstede | N/A | Netherlands | 4.62301 | 52.34992 Helmond | N/A | Netherlands | 5.66111 | 51.48167 Hilversum | N/A | Netherlands | 5.17639 | 52.22333 Nijmegen | N/A | Netherlands | 5.85278 | 51.8425 Sittard | N/A | Netherlands | 5.86944 | 50.99833 Ålesund | N/A | Norway | 6.15492 | 62.47225 Bodø | N/A | Norway | 14.37513 | 67.28267 Bærum Postterminal | N/A | Norway | N/A | N/A Bærum Postterminal | N/A | Norway | N/A | N/A Elverum | N/A | Norway | 11.56231 | 60.88191 Skien | N/A | Norway | 9.60897 | 59.20962 Bialystok | N/A | Poland | 23.16433 | 53.13333 Kielce | N/A | Poland | 20.62752 | 50.87033 Krakow | N/A | Poland | 19.93658 | 50.06143 Krakow | N/A | Poland | 19.93658 | 50.06143 Krakow | N/A | Poland | 19.93658 | 50.06143 Lodz | N/A | Poland | 19.47395 | 51.77058 Mielec | N/A | Poland | 21.4239 | 50.28709 Piekary Śląskie | N/A | Poland | 18.92653 | 50.38017 Rzeszów | N/A | Poland | 21.99901 | 50.04132 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 Bryanston | N/A | South Africa | 28.02805 | -26.05211 Johannesburg | N/A | South Africa | 28.04363 | -26.20227 Randburg | N/A | South Africa | 28.00123 | -26.0941 Sandton | N/A | South Africa | 28.054 | -26.104 Alcorcón (Madrid) | N/A | Spain | -3.82487 | 40.34582 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Hospitalet (Barcelona) | N/A | Spain | N/A | N/A Jaén | N/A | Spain | -3.79028 | 37.76922 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Móstoles (Madrid) | N/A | Spain | -3.86496 | 40.32234 Valencia | N/A | Spain | -0.37966 | 39.47391 Falköping | N/A | Sweden | 13.55068 | 58.17347 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Halmstad | N/A | Sweden | 12.85676 | 56.67446 Kalmar | N/A | Sweden | 16.36163 | 56.66157 Kungälv | N/A | Sweden | 11.98054 | 57.87096 Lidköping | N/A | Sweden | 13.15765 | 58.50517 Linköping | N/A | Sweden | 15.62157 | 58.41086 Mölndal | N/A | Sweden | 12.01378 | 57.6554 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Varberg | N/A | Sweden | 12.25078 | 57.10557

0

NCT00168818

[ 5 ]

26

RANDOMIZED

PARALLEL

1PREVENTION

3TRIPLE

false

0ALL

true

The broad, long-term objectives of this proposal are to prevent the emergence of posttraumatic stress and depressive symptoms in children admitted for an acute burn, reconstructive surgery, or non-burn injury. This study is investigating the early use of a medication in the prevention of posttraumatic stress disorder and depression. Specific Aims 1 and 2: To assess the efficacy of sertraline to prevent the development of (Aim 1)posttraumatic stress disorder and (Aim 2)depression in children aged 6-20, after burn or non-burn injury or after reconstructive surgery. Hypotheses 1 and 2: Administration of sertraline after an acute burn or non-burn injury, or after reconstructive surgery will lead to greater reduction in post-traumatic and depressive symptoms over 12 and 24 weeks, compared with placebo. This study is completing the evaluation of 90 children and adolescents, aged 6-20 years. It is comparing 60 subjects receiving sertraline with 30 placebo control subjects matched for age, severity of injury, and type of hospitalization (acute vs. reconstructive). Children and families are evaluated for the presence of acute stress symptoms. Children are reassessed in a double-blind placebo-controlled design, with evaluations at Baseline, Week 2, Week 4, Week 8, Week 12, and Week 24. In addition, there is weekly monitoring for the first 14 weeks of the study and again at 18 weeks (the midpoint of the study). At each reassessment, information is collected on the child's compliance with the study medication, the parents' assessment of the child's functioning, and the child's self-report of posttraumatic and depressive symptomatology. The main outcome variable used in this study is the child's posttraumatic symptoms.

RESEARCH DESIGN AND METHODS 1. SPECIFIC AIM 1: To assess the efficacy of sertraline in preventing posttraumatic stress disorder in children aged 6-20 after a burn, injury or reconstructive surgery following a burn injury. 2. SPECIFIC AIM 2: To assess the efficacy of sertraline in preventing co-morbid depression in children aged 6-20 after a burn, injury or reconstructive surgery following a burn injury. BACKGROUND AND SIGNIFICANCE Prevention of posttraumatic stress symptoms is a priority in psychiatric practice today. This is the first controlled study of any medication to prevent posttraumatic stress disorder (PTSD) in children and adolescents. The purpose of the study is to use sertraline to prevent PTSD and co-morbid depression from developing in 6-20 year old children hospitalized with a burn, injury, or reconstructive surgery following a burn injury. If this intervention is successful, it will help to prevent psychiatric and developmental disorders in injured children as well as those who undergo reconstructive procedures. While we have found no studies that have investigated the efficacy of sertraline in treating PTSD in children and adolescents, research indicates that sertraline is effective in treating other anxiety disorders and depression in children and adolescents. Research also indicates that sertraline is effective in treating PTSD in adults. RECRUITMENT PROCEDURES Families of children aged 6-20 admitted with an acute burn or for reconstructive surgery are contacted by study staff within 3 days of admission or when medically stable, and asked to participate in the study. In addition, 6-17 year old patients admitted for an injury are asked to participate. CONSENT PROCEDURES: A licensed physician investigator explains the nature of the study and requests consent from the child's primary caregiver or legal guardian as soon as possible after hospital admission. Once consent is given, the research coordinator obtains the baseline data. Ninety children will be enrolled in the study. These children must a) be a burn patient between the ages of 6 and 20 or an injured patient between the ages of 6-17, b) have responded to the burn, injury, or surgery with fear, helplessness, or horror, and c) be proficient in English or Spanish. If a child has no memory of the injury, currently uses antidepressants, or has a known sensitivity to sertraline, diagnosis of Bipolar disorder, diagnosis of PTSD, mental retardation, Traumatic Brain Injury, or a new onset of seizures or marked worsening of a seizure disorder, he/she will not be included in the study. STUDY PROCEDURES After the child is enrolled, he/she is randomly assigned to receive either sertraline or placebo. Neither the family nor the investigator will know which group the child is assigned to. If at any time this information becomes medically necessary, it will be made available to the child's doctor. The child takes the study medication every day for 12 weeks. If the child is in the sertraline group, the dose of medication may be increased gradually until a satisfactory response is achieved. If the child is in the placebo group, he/she may receive sertraline after 12 weeks if clinically indicated. After 12 weeks, the medication or placebo will be tapered at a rate of 25 mg every three days. All children and families are assessed at six points: Early in their acute hospitalization (Baseline), at again at weeks 2, 4, 8, 12, and 24. The baseline and follow-up assessments of 8, 12, and 24 weeks include child and parent interviews. During each assessment, the child and parent complete several questionnaires examining how the child is functioning. Check up assessments are completed as recommended by the FDA. The assessments take place in the hospital, at home, or by the telephone after the child had been discharged. EQUITABLE SELECTION OF SUBJECTS Proficiency in English or Spanish is needed in order to be included in the study as the study instruments are not validated for non-English and non-Spanish speaking populations. PRIVACY AND CONFIDENTIALITY Parents/guardians are informed that the information gathered in the study is confidential and will not adversely affect their child's treatment in any way. The child is assigned a research identification number and this number, not their name, will be placed on the study questionnaires. The document that matches name with identification number is kept in a locked cabinet that is accessible only to study staff. The data stored in the computer is password protected and computer access is limited to study staff. All interview and questionnaire data is kept in a locked cabinet. Families are also told prior to entering the study that certain information (i.e., suspicions of child abuse or neglect) cannot be confidential. EXPECTED BENEFITS The child's psychiatric symptoms may potentially decrease as a result of taking sertraline. If sertraline is found to prevent PTSD, the patient and other children will benefit from its use. In addition, the child may benefit from on-going psychological follow-up over the course of 24-weeks. At the conclusion of the study, the family has an opportunity to meet with one of the investigators and discuss the results of the evaluation. Potential benefits to society: This study may be helpful in scientifically understanding the effect of sertraline on children's psychological and physiological responses to stress. It may be satisfying to families to learn that they are contributing to a body of knowledge that may help children/adolescents who are burned or injured in other ways. It is our hope that sertraline will help to prevent the debilitating symptoms of PTSD among burned and injured children and adolescents. Because PTSD can have long-lasting impacts both on the developing brain as well as on functional development, the successful prevention of the development of these symptoms would have far-reaching beneficial implications for children suffering burn injuries, as well as those suffering other forms of physical and psychological trauma. FORESEEABLE RISKS AND DISCOMFORTS Sertraline has been shown to be well tolerated by both children and adolescents. Its side effects may include nausea, headache, stomach distress, diarrhea, dry mouth, insomnia, sexual dysfunction, sleepiness, dizziness, tremor, and fatigue. Most side effects appear early in treatment, and for about 10% of people it leads to stopping treatment. After tapering off the sertraline, these side effects will gradually stop also. Because drugs that affect the nervous system can affect judgment, thinking or coordination, subjects will be warned to be cautious about operating hazardous machinery, including automobiles, until there is reasonable certainty that subjects are not affected adversely by this drug treatment. We ask subjects to avoid alcoholic beverages during this study. It is possible that the combination of alcohol and medication may cause unknown side effects. Use of illegal drugs is prohibited. Stopping the medication abruptly may be dangerous, hence, we inform the subjects that a gradual decrease in medication dose will be necessary for medication discontinuation. The risks of suddenly stopping the mediation include the possibility of nausea, malaise, muscle aches, headaches, mood changes, and unusual sensations (numbness and tingling). Subjects should contact the investigator before discontinuing the medication. If the side effects of the medication are too uncomfortable and remain so, the sertraline may be decreased, or tapered and stopped, and alternative treatments will be offered, including counseling and/or alternative medications. If a subject remains distressed, doctors are available to help for as long as the subject is in the hospital. If, after the subject leaves the hospital and needs more treatment, the study doctors will refer him/her to a mental health professional in the community. If during this study the subject becomes distressed, he/she will have the opportunity to call and be evaluated by study staff. Individuals with bipolar disorder (manic-depressive illness) cannot participate in the study because of the risk of inducing mania or hypomania with anti-depressants. Due to potential for fatal interaction, subjects should avoid taking monoamine oxidase inhibitors (MAOIs) within at least 30 days of taking sertraline, and should avoid starting MAOI treatment until at least 30 days after discontinuation of treatment with sertraline. Subjects may experience an allergic reaction to sertraline, or placebo ingredients. If a subject experiences allergy symptoms such as rash, hives or itching, he/she should notify their doctor immediately. Untreated allergy symptoms can lead to a medical emergency. Since this is a research study and the treatments or procedures are relatively new, there may be additional risks or side effects that we do not know about at this time, but which might occur during the study or later. Subjects will be informed of any significant new information regarding sertraline that may affect their willingness to continue participation in the study. If subjects plan to take any drug other than the study medication or undergo any medical treatment, then we ask them to notify the study doctor before starting the drug or treatment. This applies to prescription drugs, over-the-counter drugs such as cough and cold remedies, antacids, investigational drugs/procedures, and sleeping medications. If surgery or a diagnostic procedure is planned, then the study doctor has to be notified before the procedure is performed. Pregnant women and nursing mothers cannot participate in this study. It is important that subjects avoid pregnancy throughout this study because the use of any drug during pregnancy has the potential to harm the embryo or the fetus. We will instruct women of childbearing potential that they must reliably practice an approved form of birth control while participating in the study. If a subject does become pregnant, she must tell the study doctor immediately. Her participation in the study may end and she may need counseling for her pregnancy. If a subject becomes pregnant during the study or 15 days after her last dose of the medication and her pregnancy is carried to term, the investigator will ask her permission to follow the course of her pregnancy and delivery as well as the condition of her newborn. If a subject misses a period or thinks she might be pregnant during the study, she must notify her study doctor immediately so that she can be withdrawn from the study. MINIMIZATION OF RISKS AND SAFETY MONITORING Source data is monitored by the co-investigators in the study. Safety and outcomes monitoring are conducted in accord with the rules and regulations of the Massachusetts General Hospital. Adverse events monitoring is conducted in accord with the policies and procedures of the Massachusetts General Hospital, and reported to the Human Research Committee of the Massachusetts General Hospital, in accord with Partners Human Research Committee Adverse Event Reporting Guidelines.

Posttraumatic Stress Disorder Depression

sertraline children adolescents posttraumatic stress disorder depression prevention burns injuries

null

2

arm 1: Placebo was administered on a flexible fixed schedule and tapered at 12 weeks. arm 2: Sertraline was administered on a flexible fixed schedule beginning at 25 mg/day and increasing as high as 150 mg/day. At week 12, the medication was tapered at a rate of 25 mg every 3 days until it was discontinued.

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: The placebo was administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the placebo was tapered at a rate of 25mg every 3 days until it was discontinued. intervention 2: The drugs were administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the medication was tapered at a rate of 25mg every 3 days until it was discontinued.

intervention 1: Placebo intervention 2: Sertraline

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00182078

[ 0 ]

20

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

This research study will look at the safety (e.g., the occurrence of side effects) and efficacy (how well the drug works in reducing trigeminal neuralgia attacks) of a drug called lamotrigine in adults with trigeminal neuralgia.

A randomized, double-blind, placebo-controlled, add-on study of lamotrigine in trigeminal neuralgia. Thirty-eight eligible patients with trigeminal neuralgia will be enrolled; nineteen will be randomized to the active medication group and nineteen to the placebo group. Using a daily diary, all patients will document their overall pain level and attack frequency and intensity for four weeks. After the four week baseline period, patients will initiate medication (lamotrigine or placebo). Patients will titrate until either they reach the maximum dose of 400mg per day and up to 700mg for patients on enzyme-inducing anti-epileptic drugs (EIAED's), their side effects inhibit further increases (known as maximum tolerated dose (MTD)), or their trigeminal neuralgia pain resolves (referred to as pain free dose (PFD)) over eight weeks. Patients will remain on a constant dose of prior medications throughout the study. Patients will remain on maximum dose, MTD, or PFD for a maintenance period of at least eight weeks, and at the end of the maintenance period patients who opt to stay on the medication will be unblinded as to medication and dosage. Primary outcome will be average intensity of daily pain.

Trigeminal Neuralgia

Double-Blind Placebo-Controlled

null

2

arm 1: Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg arm 2: Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal). This drug is an anti-seizure medication. intervention 2: The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.

intervention 1: lamotrigine intervention 2: Placebo

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00203229

[ 0 ]

112

RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to demonstrate the effectiveness and safety of the Alair System for the treatment of asthma. This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy. One-hundred and ten subjects will be randomized 1:1 to either the Alair Group (Medical management + Alair treatment),or Control Group (Medical management only).

Multicenter, randomized, controlled clinical trial conducted at 11 Investigational Sites in 4 countries (Canada, United Kingdom, Denmark, and Brazil). Subjects underwent Baseline evaluations, Alair treatments or Control Visits, and follow-up evaluations at 12-Weeks, 6-Months, and 12-Months after the last Treatment or Control Visit. In order to maximize the power of the study, Baseline and Follow-up testing was conducted in 2 parts. In the first part subjects continued to take their asthma maintenance medications (inhaled corticosteroids (ICS) and long acting β2-agonists (LABA) during the test period. This is designated as the "ON-LABA" Phase. Following ON-LABA testing subjects were asked to abstain from LABA for the second part of the testing, and these results are designated as the "OFF-LABA" Phase.

Asthma

Asthma Bronchial Thermoplasty Airway Hyperresponsiveness

null

2

arm 1: Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System. arm 2: Conventional therapy with ICS+LABA.

[ 0, 1 ]

2

[ 3, 0 ]

intervention 1: Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System. intervention 2: Conventional therapy with ICS+LABA.

intervention 1: Bronchial thermoplasty with the Alair System intervention 2: Conventional therapy with ICS+LABA

0

null

0

NCT00214526

[ 3 ]

136

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

true

SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required continued intubation and received surfactants for the prevention or treatment of respiratory distress syndrome (RDS).

Determine the safety and tolerability of SURFAXIN administration in the first weeks of life as a therapeutic approach for prevention of BPD. Determine whether treatment with SURFAXIN during the first two to three weeks of life can decrease the proportion of infants on mechanical ventilation or oxygen or the incidence of death or BPD in VLBW infants when assessed at 28 days of life and 36 weeks post-menstrual age (as determined by the need for supplemental oxygen).

Respiratory Distress Syndrome, Newborn Premature Birth Bronchopulmonary Dysplasia

Double-blind Low Birth Weight Surfactant Placebo-Controlled Premature Birth

null

3

arm 1: SURFAXIN (lucinactant) at 175 mg/kg arm 2: SURFAXIN (lucinactant) at 90 mg/kg arm 3: Sham air using 3.0 mL/kg volume of air

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Administered via slow intra-tracheal instillation at a dose of 175 mg/kg (5.8 mL/kg of a 30-mg/mL suspension). Initial treatment given no later than 1 hour after randomization. Additional treatments were administered every 48 hours up to a maximum of 5 doses (up to day of life (DOL) 18). intervention 2: Administered via slow intra-tracheal instillation at a dose of 90 mg/kg (3.0 mL/kg of a 30-mg/mL suspension). Initial treatment given no later than 1 hour after randomization. Additional treatments were administered every 48 hours up to a maximum of 5 doses (up to DOL 18). intervention 3: Sham air was administered via slow intratracheal instillation at a dose of 3.0 mL/kg volume of air. The initial treatment was given no later than 1 hour after randomization. Additional treatment were administered every 48 hours up to a maximum of 5 doses (up to DOL 18).

intervention 1: Lucinactant 175 mg/kg intervention 2: Lucinactant 90 mg/kg intervention 3: Placebo

1

Warrington | Pennsylvania | United States | -75.13406 | 40.24927

0

NCT00215540

[ 4 ]

743

NON_RANDOMIZED

FACTORIAL

0TREATMENT

0NONE

false

0ALL

null

A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

null

Excessive Daytime Sleepiness Narcolepsy Obstructive Sleep Apnea/Hypopnea Syndrome Chronic Shift Work Sleep Disorder

null

1

arm 1: Armodafinil 100 to 250 mg/day

[ 0 ]

1

[ 0 ]

intervention 1: Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD).

intervention 1: Armodafinil 100 to 250 mg/day

100

0

NCT00228553

[ 4 ]

247

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and family and/or social activities), and effects on fatigue. Clinician ratings on patient response to armodafinil treatment will also be assessed.

null

Excessive Daytime Sleepiness Narcolepsy Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: Armodafinil

43

0

NCT00228566

[ 3 ]

40

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold before apheresis, and if transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).

An open label, multi-center, phase 2 study was conducted in patients with MM or NHL who were to be treated with peripheral blood stem cells (PBSC) autologous transplantation. The only change to the standard of care was the addition of plerixafor to a mobilization regimen of chemotherapy and G-CSF. Patients were first given a mobilizing regimen of chemotherapy as per local practice guidelines and G-CSF (at customary doses) and apheresis was performed. After the first apheresis, plerixafor was given at 10PM, 10-11 hours before the second apheresis the next day or in the morning of the second day, 6 hours before the second apheresis. The change in the patient's peripheral CD34+ cell count between the plerixafor dose and the start of apheresis was measured. The apheresis yields on Day 1 and Day 2 were compared. This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Lymphoma, Non-Hodgkin Multiple Myeloma

Non-Hodgkin's Lymphoma Multiple Myeloma Stem cell mobilization

null

4

arm 1: Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days. Called 'Cohort A' in protocol, study report and publications. arm 2: Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days. Called 'Cohort B' in protocol, study report and publications. arm 3: Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of \>=10 cells/µL but \<20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days. Called 'Cohort C' in protocol, study report and publications. arm 4: This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms. Called 'Investigational Cohort' in protocol, study report and publications.

[ 0, 0, 0, 0 ]

1

[ 0 ]

intervention 1: G-CSF and plerixafor were administered as described in the treatment arms.

intervention 1: G-CSF and plerixafor

5

0

NCT00322387

[ 5 ]

41

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

1FEMALE

false

During labor there is an increased production of inflammatory mediators called cytokines. Higher concentration of certain cytokines has been linked to adverse neonatal and maternal outcomes. Epidural analgesia is commonly performed after the parturient feels labor pain. We hypothesis that preemptive epidural analgesia (initiated before labor pain begins)can influence the production of cytokines.

The interrelationship between vaginal labor, cytokine production, and epidural analgesia is unknown. Vaginal delivery is thought to induce a maternal inflammatory response. Though epidural analgesia during labor was found to significantly influence peripartum maternal and newborn interleukin concentrations, these studies did not address at what stage epidural analgesia was performed. Preemptive analgesia has been found to be associated with attenuated proinflammatory cytokines, at least in the postoperative period. Healthy ASA I term parturients (\>37 weeks) being accepted into delivery ward and wanting epidural analgesia will be studied. Parturients will be divided into two groups: * Group I- those who have painless contractions awaiting augmentation of labor. * Group II- parturients with cervical dilatation and painful labor (VAS \>5). Parturients in Group I will be given epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS\<3). Parturients in Group 2 will be given epidural analgesia as soon as possible. Epidural analgesia protocol will be identical for both groups: graduated doses of bupivicaine 0.1% 15cc and 100 mcg fentanyl followed by patient controlled analgesia at a concentration of bupivicaine 0.1% and fentanyl 2 mcg/cc delivered at 10cc per hour with possible boluses of 5 cc every ten minutes. Maternal serum will be drawn before epidural insertion and 18-24 hours after delivery. Placental blood will be drawn after delivery. These blood sample will be assessed for IL-1Beta, TNF alpha, IL-1ra, IL-2, Il-6, IL-8, IL-10, IL-18. The patient's chart will be prospectively analyzed for demographic information about parturient and complications and progress of labor.

Obstetric Pain

Epidural analgesia labor cytokines

null

2

arm 1: Parturients will receive epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS\<3). arm 2: Parturients with cervical dilatation and painful labor (VAS \>5) will receive epidural analgesia as soon as possible

[ 0, 1 ]

2

[ 3, 0 ]

intervention 1: Parturients will receive early epidural analgesia before onset of painful contractions as oppose to standard of care in which parturients receive epidural analgesia with onset of painful contractions. intervention 2: Epidural analgesia with parturients with cervical dilatation and painful labor (VAS \>5)

intervention 1: Preemptive epidural analgesia intervention 2: Standard of care

1

Petah Tikva | N/A | Israel | 34.88747 | 32.08707

0

NCT00361712

[ 4 ]

82

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.

null

Insomnia

null

6

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

[ 0, 0, 0, 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved. intervention 2: Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved. intervention 3: Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

intervention 1: zolpidem tartrate sublingual tablet 3.5mg intervention 2: zolpidem tartrate sublingual tablet 1.75mg intervention 3: Placebo

0

null

0

NCT00380081

[ 2 ]

318

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

null

This study will evaluate the bioequivalence of alendronate in combination with vitamin D compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone. This was an open-label, randomized, 2-part, crossover study. Each participant participated in one part of the study only (i.e., each participant participated only in Part I or only in Part II). Participants entered the study sequentially within each part of the study. A washout of at least 12 days separated each treatment period within each part of the study.

null

Osteoporosis

null

4

arm 1: Participants in Part 1 received 70mg alendronate+5600 International Units (IU) vitamin D combination tablet in Period 1 followed by 70mg alendronate tablet in Period 2. A washout of at least 12 days separated each treatment period. arm 2: Participants in Part 1 received 70mg alendronate tablet in Period 1 followed by 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period. arm 3: Participants in Part 2 received 70mg alendronate+5600 IU vitamin D combination tablet in Period 1 followed by a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 2. A washout of at least 12 days separated each treatment period. arm 4: Participants in Part 2 received a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 1 followed by a 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.

[ 0, 0, 0, 0 ]

3

[ 0, 0, 7 ]

intervention 1: A single dose tablet of 70mg alendronate sodium+5600 IU vitamin D combination tablet in one treatment period of each sequence. intervention 2: A single dose tablet of 70mg alendronate in one treatment period of each sequence. intervention 3: Two tablets of 2800 IU vitamin D, totaling 5600 IU, in one treatment period of each sequence.

intervention 1: alendronate sodium+vitamin D combination intervention 2: Comparator: alendronate intervention 3: Comparator: Vitamin D

0

null

0

NCT00803790

[ 3 ]

320

null

0ALL

null

Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in patients with dry eye, using a multicenter, randomized, double-blind, parallel group comparison study, and the optimal concentration is determined.

null

Dry Eye

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None

intervention 1: DE-089 ophthalmic solution intervention 2: DE-089 ophthalmic solution intervention 3: Placebo ophthalmic solution

1

Osaka | Osaka | Japan | 135.50107 | 34.69379

0

NCT01189032

[ 2 ]

32

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

false

Single centre, open-label, randomised study in four parallel groups of healthy volunteers

Single centre, open-label, randomised study in four parallel groups of healthy volunteers: Group 1 = 900 mg of eslicarbazepine acetate (ESL, BIA 2-093); Group 2 = 450 mg of S-licarbazepine plus 450 mg of R-licarbazepine; Group 3 = 450 mg of S-licarbazepine; Group 4 = 450 mg of Rlicarbazepine. In each group, the study consisted of a single-dose period (Phase A) followed by a repeateddose period of 7 days of duration in which the investigational product was administered once daily (Phase B). The repeated-dose phase started 96 h post single-dose.

Epilepsy

null

4

arm 1: 900mg of eslicarbazepine acetate (ESL, BIA 2-093) arm 2: 450 mg of S-licarbazepine plus 450 mg of R-licarbazepine arm 3: 450 mg of S-licarbazepine arm 4: 450 mg of Rlicarbazepine

[ 0, 1, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Tablets containing 900 mg intervention 2: capsules containing 225 mg intervention 3: capsules containing 225 mg

intervention 1: BIA 2-093 intervention 2: S-licarbazepine intervention 3: R-licarbazepine

1

Hamburg | N/A | Germany | 9.99302 | 53.55073

0

NCT02281591

[ 4 ]

301

RANDOMIZED

PARALLEL

0TREATMENT

null

false

0ALL

null

The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 6 Weeks in Adult and Adolescent Subjects 12 years of Age and Older with Perennial Allergic Rhinitis (PAR)

Rhinitis, Allergic, Perennial

GW685698X perennial allergic rhinitis allergic rhinitis

null

2

arm 1: Participants were instructed to administer two sprays into each nostril once daily every morning of fluticasone furoate 110 μg arm 2: Participants were instructed to administer two sprays into each nostril once daily every morning of placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: fluticasone furoate 110 μg nasal spray intervention 2: placebo nasal spray

intervention 1: FF intervention 2: Placebo

42

0

NCT00289198

[ 4 ]

84

RANDOMIZED

SINGLE_GROUP

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to assess the efficacy and safety of Icatibant, a bradykinin antagonist in the treatment of acute cutaneous and/or abdominal attacks in patients with hereditary angioedema (HAE).

This Phase II/III study consisted of two parts: A controlled phase and An Open label extension(OLE) phase. The controlled phase describes the double blind part of the study and was intended to evaluate the efficacy of icatibant in decreasing the time to onset of symptom relief compared with placebo for the first treated cutaneous and/or abdominal attack in randomised patients. Patients experienced a laryngeal attack were not randomised, but treated with open label icatibant according to the controlled phase procedures and assessments. The outcome of this group was to be reported descriptively. After treatment of the first attack in the controlled phase, the patients were eligible to enter the OLE phase. In the OLE phase, patients who experienced angioedema attacks severe enough to warrant treatment were to be treated with s.c. icatibant as appropriate until the end of the study.The OLE phase became a modified open label extension where all 56 patients who had been randomised and the last randomised patient had concluded the double-blind phase. The modified open label extension period permitted treatment for patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the double blind phase was still ongoing.

Angioedema

Hereditary Angioedema C1 inhibitor deficiency HAE Icatibant Bradykinin antagonist acute attack subcutaneous

null

4

arm 1: Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack. arm 2: Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack. arm 3: Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase. arm 4: Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing (they were not treated during the Controlled phase but treated with icatibant during the Open Label Extension Phase (OLE) )

[ 0, 2, 0, 0 ]

2

[ 0, 0 ]

intervention 1: 30 mg (3mL) subcutaneous icatibant injection in the abdominal region intervention 2: Solution for injection, matched to study drug Single dose: 3 mL

intervention 1: Icatibant intervention 2: Placebo

1

Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511

0

NCT00097695

[ 4 ]

114

RANDOMIZED

PARALLEL

1PREVENTION

null

false

0ALL

false

This study is requested by PMDA to confirm the optimal dose for THR (total hip replacement).

null

Thrombosis, Venous

Fondaparinux Hip Replacement Arthroplasty VTE THR MOSLL pentasaccharide Xa factor

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: Fondaparinux

1

N/A | N/A | N/A | N/A | N/A

0

NCT00320398

[ 3 ]

375

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This is a 24-week study investigating the safety and efficacy of several dosages of a potential new oral medicine for Type II diabetes mellitus.

A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of GW823093, Administered Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus followed by a 12-week Active Treatment Extension

Diabetes Mellitus, Type 2

NIDDM

null

6

arm 1: Participants received oral dose of matching placebo capsule to denagliptin (DEN) once daily in the morning, 30 minutes (min) prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 milligram (mg) once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants. arm 2: Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants. arm 3: Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants. arm 4: Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants. arm 5: Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants. arm 6: Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.

[ 2, 0, 0, 0, 0, 0 ]

6

[ 0, 0, 0, 0, 0, 0 ]

intervention 1: Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads. intervention 2: DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads. intervention 3: DEN 7.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads. intervention 4: DEN 15 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads. intervention 5: DEN 30 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads. intervention 6: DEN 45 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

intervention 1: Placebo intervention 2: DEN 2.5 mg intervention 3: DEN 7.5 mg intervention 4: DEN 15 mg intervention 5: DEN 30 mg intervention 6: DEN 45 mg

109

0

NCT00111800

[ 4 ]

85

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

Primary Outcome Measures: The primary endpoint was the time to onset of symptom relief of the first attack in the double blind phase. H0: λ icatibant/λ tranexamic acid =1 versus H1: λ icatibant/λ tranexamic acid ≠1 Where: λ icatibant refers to the hazard rate under icatibant and λ tranexamic acid refers to the hazard rate under tranexamic acid. Secondary Outcome Measures: * Additional efficacy assessments (Time to Almost Complete Symptom Relief) * Safety and tolerability * Pharmacoeconomics

This was a Phase III, randomised, double blind, double dummy, multicentre, controlled,parallel group study of a 30 mg s.c. formulation of icatibant for the treatment of patients with moderate to very severe symptoms of cutaneous and/or abdominal symptoms of HAE. The study consisted of two parts: controlled phase and OLE phase. For the primary endpoint, Efficacy was determined by evaluating the differences in study outcomes using a Visual Analogue Scale for patients treated with icatibant and tranexamic acid.

Hereditary Angioedema

null

4

arm 1: Subjects received S.C icatibant+ oral placebo Icatibant Form: solution for injection, 3 mL, 10 mg/mL Single dose: 30 mg (3 mL) Placebo Form: hard capsule Single dose: 2 capsules Frequency: 3 x 2 capsules for 2 days, taken orally, 6 to 8 hours apart arm 2: Subjects received oral Tranexamic acid+ S.C. placebo Tranexamic acid Form: over encapsulated film tablet Single dose: 1000 mg (2 capsules) Frequency: 3 x 2 capsules for 2 days, taken orally, 6 to 8 hours apart Placebo Form: solution for injection, matched to icatibant for injection Single dose: 3 mL Frequency: one subcutaneous injection in the abdominal region arm 3: Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase. arm 4: Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing were treated in the open label phase with icatibant

[ 0, 1, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Icatibant: a stable, synthetic decapeptide and specific BK B2 receptor antagonist. intervention 2: over encapsulated film tablet an anti-fibrinolytic agent,is used in some European countries for the treatment of acute oedema episodes and the continuous prophylaxis of HAE. intervention 3: hard capsule matched to tranexamic acid intervention 4: solution for injection, matched to icatibant for injection

intervention 1: Icatibant intervention 2: Tranexamic Acid intervention 3: Oral Placebo intervention 4: S.C. Placebo

1

Milan | N/A | Italy | 12.59836 | 42.78235

0

NCT00500656

[ 5 ]

384

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

null

Genital herpes (GH) is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are two types of HSV, type 1 (HSV-1) and type 2 (HSV-2); both can cause GH, although the latter is much more likely to produce frequent recurrences of GH lesions. Evidence suggests that there are advantages to using suppressive vs. episodic treatment, which include increased intervals between the pain and discomfort of genital herpes recurrences. Therefore, this study will collect safety and efficacy data on suppressive therapy with valaciclovir in subjects newly diagnosed with HSV-2 genital herpes.

null

Herpes Genitalis

VALTREX® valaciclovir genital herpes HSV-2 suppression

null

2

arm 1: Participants received double blinded treatment of oral dose of Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). arm 2: Participants received double blinded treatment of oral dose of matching placebo to Valacyclovir 1 gram (g) given as 2 x 500 milligram (mg) caplets once daily (QD) for 6 months (24 weeks).

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 1g once daily intervention 2: placebo

intervention 1: Valaciclovir intervention 2: Placebo

72

0

NCT00158860

[ 4 ]

302

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.

null

Schizophrenia

Schizophrenia Aripiprazole

null

3

arm 1: Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25 arm 2: Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25 arm 3: Participants were given a single pill administered once daily

[ 1, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Aripiprazole tablet 10 mg po qd x 42 days intervention 2: Aripiprazole tablet 30 mg po qd x 42 days intervention 3: Placebo tablet po qd x 42 days

intervention 1: Aripiprazole tablet, 10 mg intervention 2: Aripiprazole tablet, 30 mg intervention 3: Placebo tablet

55

1

NCT00102063

[ 3 ]

34

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This 11-week study will examine the safety and effectiveness of the medication donepezil (Aricept®) compared to placebo for treating cognitive deficits in children and adolescents with Autism Spectrum Disorder.

Children with autism spectrum disorder (ASD) often have impaired communication, problems with social interaction, and repetitive and stereotyped patterns of behavior. While most research has attempted to treat the behavioral deficits commonly associated with ASD, few studies have attempted to improve the core features of this disorder. A recent study found that donepezil HCl helped to improve speech production, attention span, and ability to express emotions in a group of children with autism. This study will provide an opportunity to conduct further testing of the effects of donepezil HCl on the cognitive deficits presumed to underlie the core features of ASD. This study begins at Week 1 with a baseline assessment. Participants are then randomly assigned to either donepezil HCl or placebo. Participants will start with either a 5mg/day dose of donepezil HCl or placebo followed by a cognitive assessment after 4 weeks on this dose. Participants will then have their dose increased to 10mg/day. Another cognitive assessment will be given after 4 weeks on this dose.

Autistic Disorder

null

2

arm 1: Donepezil HCL 5 mg and 10 mg arm 2: Placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks. intervention 2: Placebo used in placed of Donepezil HCL

intervention 1: Donepezil HCl intervention 2: Placebo

1

Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062

0

NCT00047697

[ 3 ]

60

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety administered to patients with bloodstream infections and whether telavancin is effective in treating these infections.

null

Gram-Positive Bacterial Infections

null

2

arm 1: None arm 2: Vancomycin 1 Gram/12 hours or nafcillin, oxacillin, or cloxacillin 2 Gram/6 hours (IV) intravenously

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days intervention 2: Vancomycin 1 Gram every 12 hr IV (intravenously) OR nafcillin, oxacillin, or cloxacillin 2 Grams every 6 hr IV (intravenously) for up to 14 days.

intervention 1: Telavancin intervention 2: Vancomycin, nafcillin, oxacillin, or cloxacillin

1

Marietta | Georgia | United States | -84.54993 | 33.9526

0

NCT00062647

[ 4 ]

627

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

null

Colorectal Cancer

null

2

arm 1: Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m\^2 intravenous (IV) infusion over 2 hours (every 3 weeks \[Day 1\]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks). arm 2: Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin \[LV\] and 5-fluorouracil \[5-FU\] combination). Oxaliplatin was administered as an 85 mg/m\^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m\^2 over 2 hours followed by 5-FU, given as 400mg/m\^2 bolus injection over 2-4 minutes, and then as a 600 mg/m\^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m\^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).

[ 0, 1 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: As prescribed, in 2 week cycles intervention 2: As prescribed, in 2 week cycles intervention 3: As prescribed, in 3 week cycles intervention 4: As prescribed, in 2 week cycles intervention 5: 1000mg/m2 po bid on days 1-15 of each 3 week cycle

intervention 1: 5 FU intervention 2: Leucovorin intervention 3: Oxaliplatin intervention 4: Oxaliplatin intervention 5: capecitabine [Xeloda]

87

Bakersfield | California | United States | -119.01871 | 35.37329 Colorado Springs | Colorado | United States | -104.82136 | 38.83388 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Terre Haute | Indiana | United States | -87.41391 | 39.4667 St Louis | Missouri | United States | -90.19789 | 38.62727 Billings | Montana | United States | -108.50069 | 45.78329 Nyack | New York | United States | -73.91791 | 41.09065 Dallas | Texas | United States | -96.80667 | 32.78306 Brussels | N/A | Belgium | 4.34878 | 50.85045 Brussels | N/A | Belgium | 4.34878 | 50.85045 Ghent | N/A | Belgium | 3.71667 | 51.05 Kortrijk | N/A | Belgium | 3.26487 | 50.82803 Mont-godinne | N/A | Belgium | N/A | N/A Edmonton | Alberta | Canada | -113.46871 | 53.55014 St. John's | Newfoundland and Labrador | Canada | -52.70931 | 47.56494 Halifax | Nova Scotia | Canada | -63.57688 | 44.64269 London | Ontario | Canada | -81.23304 | 42.98339 Oshawa | Ontario | Canada | -78.84957 | 43.90012 Ottawa | Ontario | Canada | -75.69812 | 45.41117 Saint Catherines | Ontario | Canada | N/A | N/A Thunder Bay | Ontario | Canada | -89.25018 | 48.38202 Toronto | Ontario | Canada | -79.39864 | 43.70643 Weston | Ontario | Canada | -79.51513 | 43.70359 Laval | Quebec | Canada | -73.692 | 45.56995 Lévis | Quebec | Canada | -71.17793 | 46.80326 Montreal | Quebec | Canada | -73.58781 | 45.50884 Montreal | Quebec | Canada | -73.58781 | 45.50884 Montreal | Quebec | Canada | -73.58781 | 45.50884 Québec | Quebec | Canada | -71.21454 | 46.81228 Regina | Saskatchewan | Canada | -104.6178 | 50.45008 Split | N/A | Croatia | 16.43915 | 43.50891 Zagreb | N/A | Croatia | 15.97798 | 45.81444 Tampere | N/A | Finland | 23.78712 | 61.49911 Turku | N/A | Finland | 22.26869 | 60.45148 Avignon | N/A | France | 4.80892 | 43.94834 Bordeaux | N/A | France | -0.5805 | 44.84044 Bordeaux | N/A | France | -0.5805 | 44.84044 Chambray-lès-Tours | N/A | France | 0.70286 | 47.33537 Limoges | N/A | France | 1.24759 | 45.83362 Nîmes | N/A | France | 4.35788 | 43.83665 Pessac | N/A | France | -0.6324 | 44.80565 Rouen | N/A | France | 1.09932 | 49.44313 Tübingen | N/A | Germany | 9.05222 | 48.52266 Heraklion | N/A | Greece | 25.14341 | 35.32787 Thessaloniki | N/A | Greece | 22.93086 | 40.64361 Beersheba | N/A | Israel | 34.7913 | 31.25181 Jerusalem | N/A | Israel | 35.21633 | 31.76904 Kfar Saba | N/A | Israel | 34.90694 | 32.175 Petah Tikva | N/A | Israel | 34.88747 | 32.08707 Ramat Gan | N/A | Israel | 34.81065 | 32.08227 Rehovot | N/A | Israel | 34.81199 | 31.89421 Tel Aviv | N/A | Israel | 34.78057 | 32.08088 Bergamo | N/A | Italy | 9.66721 | 45.69601 Cattolica | N/A | Italy | 12.73631 | 43.96182 Rimini | N/A | Italy | 12.56528 | 44.05755 Udine | N/A | Italy | 13.23715 | 46.0693 Bialystok | N/A | Poland | 23.16433 | 53.13333 Krakow | N/A | Poland | 19.93658 | 50.06143 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 San Juan | N/A | Puerto Rico | -66.10572 | 18.46633 Belgrade | N/A | Serbia | 20.46513 | 44.80401 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Ljubljana | N/A | Slovenia | 14.50513 | 46.05108 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Durban | N/A | South Africa | 31.0292 | -29.8579 Pietermaritzburg | N/A | South Africa | 30.39278 | -29.61679 Port Elizabeth | N/A | South Africa | 25.61494 | -33.96109 Pretoria | N/A | South Africa | 28.18783 | -25.74486 Buchun | N/A | South Korea | 126.91475 | 34.71258 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Barcelona | N/A | Spain | 2.15899 | 41.38879 Leganés | N/A | Spain | -3.7635 | 40.32718 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Palma de Mallorca | N/A | Spain | 2.65024 | 39.56939 Kueishan | N/A | Taiwan | N/A | N/A Tainan City | N/A | Taiwan | 120.21333 | 22.99083 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Denbigh | N/A | United Kingdom | -3.41667 | 53.18333 Manchester | N/A | United Kingdom | -2.23743 | 53.48095 Merseyside | N/A | United Kingdom | N/A | N/A Preston | N/A | United Kingdom | -2.70452 | 53.76282

0

NCT00069108

[ 0 ]

307

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

1FEMALE

true

The primary aim of this study is to test if the addition of behavioral treatment to drug therapy for the treatment of urge incontinence will increase the number of patients who can discontinue drug therapy and sustain a significant reduction of incontinence.

null

Urinary Incontinence (UI)

Urge urinary incontinence (UUI) Drug/Behavior treatment

null

2

arm 1: Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training. arm 2: Women assigned to this arm received 10 weeks of anti-cholinergic medication (tolterodine), only.

[ 0, 1 ]

2

[ 0, 5 ]

intervention 1: 4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects. intervention 2: Training in pelvic floor muscle control and exercises; behavioral strategies to diminish urgency, suppress bladder contractions and prevent incontinence; delayed voiding; and individualized fluid management.

intervention 1: Tolterodine intervention 2: Behavioral training

9

0

NCT00090584

[ 4 ]

205

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

Migraines are a specific type of headache that frequently recur and are very painful. Although there are many medications that are effective against migraines, none of these medications cure 100% of migraines. Another problem with migraines is that although many times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3 of the time migraines recur the next day. The purpose of this research project is to see if adding a medication called dexamethasone to standard ER therapy will help patients get better quicker and stay pain-free more often than if they receive placebo.

Parenteral Corticosteroids as Adjuvant Therapy for Migraine Headaches: A. Overview/Aims: Five million Americans present to emergency departments (ED) annually with headaches \[1\]. The majority of these patients have migraine headaches \[2,3\]. Parenteral medications of proven benefit for acute migraines include the triptans \[4\], dopamine-receptor antagonists \[5-11\], non-steroidals \[12\], and dihydroergotamine \[13\]. Although these distinct classes of medication are often effective for the treatment of acute migraines, their use is complicated by treatment failures \[4,9,14\], recurrence of headache \[15,16\], and side effects \[17\], all of which are of concern for patients with migraines \[18\]. The ideal medication, which would rapidly alleviate migraine pain without any recurrence of pain or side effects, has not yet been identified. The role of corticosteroids in acute migraines is ill-defined. Although used in patients with intractable migraines, this class of medication is not widely used in typical migraine attacks. However, limited clinical data suggest that corticosteroids decrease the rate of recurrent headaches \[19-21\] and might decrease the pain of an acute attack \[22\]. Further research is needed to define the role of corticosteroids in the ED treatment of acute migraine headaches. Specific Aim: The specific aim of this study is to determine the efficacy of ten milligrams of parenteral dexamethasone as adjuvant therapy for the emergency department treatment of migraine headaches. Primary Hypothesis: Twenty four hours after medication administration, a greater percentage of migraine subjects who received dexamethasone will have: * sustained pain-free headache relief; and * no headache-related functional impairment when compared to subjects who receive placebo. Both groups will also receive the standard of care. Secondary Hypothesis: Two hours after medication administration, a greater percentage of migraine subjects who received dexamethasone will be headache pain-free, when compared to subjects who receive placebo. B. Background and Significance: Despite standard treatment, a large percentage of emergency migraineurs continue to suffer from headaches after ED discharge. Recurrent or persistent headaches rated as moderate or severe in intensity occurred in 14-43% of subjects 24 hours after discharge in ED-based migraine clinical trials \[20,23,24\]. In a Canadian population, 45% of headache patients reported headache-related functional impairment within 24 hours of ED discharge \[16\]. Some reports indicate that corticosteroids decrease the rate and intensity of recurrent migraine headaches \[19-21\]. However, the investigators could not find any corticosteroid clinical trials using recommended measures and outcomes \[25\] in a migraine population. To the best of their knowledge, no controlled clinical trial has tested the efficacy of corticosteroids as primary migraine-abortive therapy. Although the pathogenesis of migraine headaches is incompletely understood, a sterile neurogenic inflammation is felt to be key to the pain generating pathway that occurs in acute migraines \[15\]. Corticosteroids theoretically mitigate this inflammation and decrease the pain and duration of acute migraine attacks. One dose of intravenous dexamethasone has been well-tolerated in migraineurs \[20\]. If this medication proves to have efficacy for migraines, then this would represent a substantial contribution to headache medicine, an effective tool in the armamentarium of emergency physicians, and a cheap and safe method to decrease the pain and suffering of ED migraine patients. C. Methods: C1. Overview: This will be a randomized, double-blind, placebo-controlled clinical research trial testing the efficacy of intravenous dexamethasone sodium phosphate as adjuvant therapy for acute migraine headaches. All subjects will receive standard-of-care migraine-abortive medication for their migraines. In addition, they will receive either ten milligrams of intravenous dexamethasone sodium phosphate or a comparable amount of placebo. Subjects will be followed by telephone 24 hours after medication administration. C2. Study Sites: Study sites will include the emergency departments of Montefiore Medical Center, Jacobi Medical Center, New York Presbyterian Hospital, St. Luke's Medical Center, Bellevue Medical Center, and Kings County Medical Center. C3. Selection of Participants: The attending emergency physician will refer all adult patients who present with a chief complaint of headache during the regular hours of the data collectors. Under the supervision of the site investigators, the data collectors will inform patients about the study and ask for their consent to participate in this study as human subjects. The data collectors will include in this study any patient who has a migraine headache as defined by the International Headache Society (IHS-2003 1.1 migraine without aura; 1.2 migraine with aura). Patients will also be included if they have an IHS probable migraine (IHS-2003 1.6.1 \& 1.6.2) \[26\] that has lasted between 72 and 168 hours. In other words, patients will also be included if their headache meets all IHS migraine criteria except that the duration of the headache has been between 73 and 168 hours. These probable migraine patients will be included because they represent a substantial subset of ED primary headache patients (Friedman, et. al., unpublished data) and because the majority of patients with a disabling probable migraine and a history of similar headaches will respond to migraine-specific medication \[27\]. Patients will be excluded if the emergency physician intends to perform a lumbar puncture in the ED because lumbar puncture has an independent association with 24 hour headache pain scores. Patients will be excluded for persistent objective focal neurologic deficits, as determined by the attending physician, for fear of mistaking a stroke for a complicated migraine, or for signs and symptoms concerning for other causes of malignant secondary headache such as meningitis, subarachnoid hemorrhage, carotid dissection, or intracranial mass. Patients will also be excluded for temperatures greater than 100.3 degrees, pregnancy or lactation, or allergy or intolerance to any of the study medications. Patients can only enroll once. Patients over the age of 64 will be excluded, for fear of increased risk of adverse reactions to study medications and increased risk of secondary headaches. Patients who do not meet enrollment criteria will have basic demographic and headache variables recorded. C4. Randomization and Blinding: Randomization is to be done by the research pharmacist at Montefiore Medical Center in blocks of six using computer generated random number tables available online. The randomization will be stratified by study site. In an order determined by the random number tables, the pharmacist will insert medication into vials and place these vials into sequentially numbered brown paper research bags. The research bags will be distributed by express courier in batches of six to the investigators at each site. The research bags will be stored at each site in a locked location accessible to the data collectors. When a subject has been identified, the contents of each research bag will be administered by a clinical nurse. Assignment will be known only by the research pharmacist. However, the assignment will accompany each research bag, sealed in a small manila envelope, in case a medical emergency mandates that the assignment be revealed. C5. Measures: C5a. Categorical Scale: As a primary measure, this trial will use the four point descriptive scale recommended for use in migraine research \[25\]. On this scale, subjects are asked to characterize their migraine pain as "none, mild, moderate or severe". C5b. Disability Scale: A descriptive categorical scale will be used to characterize the subject's headache-related disability. On this scale, subjects describe their disability as "1) none; 2) mildly impaired (having a little bit of difficulty doing what I usually do); 3) moderately impaired (having a great deal of difficulty doing what I usually do and can only do very minor activities); or 4) severely impaired (requiring bed rest)" \[25\]. C5c. Numerical Rating Scale for Pain: An 11-point verbal numerical rating scale for pain will be a secondary measurement tool for this trial. On this scale, subjects are asked to describe their pain as a number between zero and ten, with zero being no pain and ten being the worst pain imaginable. This scale has been shown to perform comparably to a visual analog scale, while being easier to administer \[28\]. C6.Outcomes: The primary outcome will be the percentage of subjects who achieve and maintain a "headache pain free" state. Persistent "headache pain free" is the recommended outcome for migraine clinical research \[25\]. Subjects will be considered to have fulfilled the primary outcome if they achieve a pain free state in the ED and maintain this throughout the 24 hour period after receiving study medication. The alternate primary outcome will be the number of subjects who report no headache-related disability for the period of time after ED discharge. The major secondary outcome will be the percentage of subjects who report a "headache pain-free" status two hours after medication administration. Other secondary outcomes include rates of sustained headache relief (moderate or severe pain becoming and maintaining a level of mild or none), two-hour NRS change (NRSbaseline-NRS2hours), 24 hour NRS change (NRSbaseline-NRS24hours), need for rescue medication before two hours, need for analgesic medication after discharge from the ED, associated symptoms (specifically: weakness, drowsiness, dizziness), unscheduled visits to a medical provider within 24 hours of medication administration, and the percentage of patients who answer affirmatively to the question "Do you want to receive the same medication the next time you come to the ED?" C7. Data Collection, Data Entry, and Back-Up: Data entry and follow-up of subjects will be accomplished by taking advantage of the research infrastructure in place at the Department of Emergency Medicine of the Albert Einstein College of Medicine. Five full-time research assistants and one research clerk are funded by the department. The research assistants are medical technician level, full-time employees who have extensive clinical research experience and have passed required research ethics courses. These research assistants staff the Montefiore ED during all operational hours. The initial data collection process will be performed by the data collectors at each individual site. These data collectors will be different in each ED, depending on the resources at the individual ED. At Montefiore and Jacobi, the data collectors are salaried, trained, technician level employees, who have passed required research ethics courses. The data collectors will be trained for this particular study by the principal investigator and site investigators. Their training will include mock patient encounters. The data collectors will use a standardized data collection instrument to collect baseline information, pain scores, and side effects in the ED. After the ED data have been obtained, the data collection instrument will be photocopied and faxed to a dedicated research clerk in the Department of Emergency Medicine at Albert Einstein College of Medicine. The receiving fax machine is a private fax machine secured in an office behind two locked doors. The research clerk will be responsible for obtaining the 24 hour follow-up information. At a time pre-arranged with the subject prior to the subject's discharge from the ED, the research clerk will call the subject and obtain 24 hour follow-up information by reading questions off of the data collection instrument. Twenty-four hour follow-up to be done during non-business hours will be performed by Montefiore's research assistants, who cover the ED 24 hours a day, seven days every week. These research assistants will retrieve the faxed data collection instruments, obtain the follow-up information, and then return the data collection instruments to the research clerk. The research clerk will enter all data into SPSS data entry V.11. Completed data collection instruments will be sent to a second research clerk who will enter the data a second time into the same SPSS program. After every ten subjects have been entered, data will be backed up and stored on three different computers on two distinct campuses. Prior to all analyses, the two data sets will be compared. Discrepancies will be corrected using the initial data collection instrument as the source. The original version of each data collection instrument will be kept in a locked cabinet at its original site. C8. Medications: In addition to study medication or placebo, all subjects will receive standard migraine abortive therapy. The optimal migraine-abortive/analgesic medication for ED patients with acute migraine headaches has not yet been defined, so the investigators have chosen intravenous metoclopramide, an effective, safe, widely-available, and economical dopamine receptor antagonist, as the migraine treatment for this trial. Parenteral dopamine-antagonists are recommended for use in the ED29 and are used more commonly than triptans in the ED setting \[1,16\]. Metoclopramide has been shown to be at least as effective as subcutaneous sumatriptan at reducing pain \[7,8\] with comparable two hour activity limitations \[30\]. The investigators will use 20 milligrams of intravenous metoclopramide, a moderate dose when compared to their previous work \[23,30\]. In addition to metoclopramide, each subject will also receive 25mg of diphenhydramine to prevent akathisia and other extra-pyramidal reactions to the metoclopramide \[31\]. This combination of metoclopramide and diphenhydramine is commonly used in the ED setting and does not cause significant drowsiness or impairment of activities in migraineurs at two hours \[30\]. The investigators view the potential anti-migraine effect of diphenhydramine \[32\] as added benefit for their subjects. Metoclopramide, diphenhydramine, and the study medication will be placed into a 50cc bag of normal saline and administered as a slow intravenous drip over twenty minutes. Subjects who require rescue medication for persistent headache will receive another 20mg of intravenous metoclopramide. This additional dose of metoclopramide is part of an ED-based protocol that has demonstrated a high rate of pain relief and patient satisfaction with a minimum of side effects \[23,30\]. Subjects who require more pain medication will receive a combination of ibuprofen and oral opiates at the discretion of the treating physician. All subjects will be discharged from the ED with two 400mg tablets of ibuprofen to be taken as needed for recurrence of headache. Ibuprofen is an effective migraine treatment \[9\]. C9. Interim Analysis, Stopping Rules and Sample Size Calculation: An interim analysis will be performed to detect an overwhelming superiority of the intervention. A data monitoring committee will convene after 126 subjects have been enrolled. The committee will look for a statistically significant difference in the primary outcome or a discrepancy in the rate of adverse effects (measured by rate of hospitalization for presumed adverse reaction to medication). The medications used in this study are well-known to the medical community and commonly used. Neither the disease nor the medications cause mortality or significant permanent disability. Therefore, although the investigators will monitor the adverse effects that occur during this trial, they do not anticipate that this will have a significant effect on the outcome. There are many different approaches to calculation of significance criteria that can be used in interim analyses, and thus might be used to terminate a trial before the complete data are collected. The investigators have chosen an intermediate approach, based on the O'Brien-Fleming procedure \[33\] and set the interim test criterion at 0.01, and the final test criterion at 0.04. Using a criterion for significance of 0.04 and a 2-tailed test, this study will require 100 subjects in each group, for a total of 200 subjects, to have power of 80% to yield a statistically significant result. This computation assumes that the difference in persistent headache pain-free proportions is 0.20, specifically, 0.30 versus 0.50 (the rate of persistent headache pain-free 24 hours after ED discharge in a previous similarly-dosed metoclopramide trial was 30% \[30\]). The clinical effect being sought is comparable to a number needed to treat of five, the largest number needed to treat believed important to discover for this self-limited disease process. The interim analysis will have adequate power (0.80) to discover a statistically significant difference (alpha=0.01) if the difference between the two groups is 30% (.60 versus .30). C10. Co-Variates: The following variables will be assessed: C10a. Cutaneous Allodynia: Cutaneous allodynia is felt to be a marker of more intractable migraines \[34\] and can be tested for by lightly rubbing a 4 x 4 piece of gauze on the face of the subject \[35\]. The data collectors will assess each subject for cutaneous allodynia prior to the administration of medication. C10b. Duration of Headache: Although likely to be collinear with allodynia, this co-variate might be associated with intractable 24 hour headaches \[20\]. C10c. Pre-Medication: In previous work, although 25% of the investigators' population took no analgesic medication prior to presentation to the ED, this co-variate did not confound the association between study medication and persistent pain-free \[30\]. Nevertheless, the investigators will record all migraine-relevant medications used by their subjects prior to ED presentation, group these by class, and determine if this co-variate has a relationship with the primary outcomes. C11d. Aura: The investigators know of no documented association between aura and corticosteroids, but this subject has been inadequately explored. C11e. Prophylactic Medications: In previous work \[30\], only a small minority of ED migraineurs were on prophylactic medication. However, these patients represent a sub-set of migraineurs with more severe disease. C11f. Chronic Migraines: Only a small minority of ED migraineurs can be classified as chronic (Friedman, unpublished data). However, these patients represent a sub-set of migraineurs at high risk of recurrent 24 hour headaches. C11g. Medication-Rebound Headaches: This diagnosis has been inadequately explored in the ED setting and consists of complicated headache patients. The investigators will not exclude these patients from this study because they are likely to benefit from this intervention \[21\]. C11h. Site: To account for site-specific differences from influencing the results, subjects from each site will be randomized in blocks of six to prevent unequal representation of a particular site in either arm. This will prevent any one site from overly influencing the study. C11i. Race/Ethnicity: This will be based on subject's report. The significance of this co-variate for this study is unknown. C11j. Age: This will be recorded. The significance of this co-variate for this study is unknown. C12k.Gender: This will be recorded. The significance of this co-variate for this study is unknown. C12. Analysis: The data will be analyzed in an "intention-to-treat" manner. Once a patient is randomized and receives the dexamethasone, their pain scores will be included in the 24-hour analysis regardless of whether or not they received rescue medication or completed the protocol. However, lost-to-follow-up subjects will be excluded from the primary analysis (a sensitivity analysis will be conducted in which lost-to-follow-up subjects are assumed to have a poor outcome). Study enrollment will continue until the pre-determined number of subjects have completed the primary endpoint. Chi-square analysis will be used to compare rates. Students t-tests will be used to compare mean differences in pain scores. Multivariate regression models will be used to analyze the influence of the co-variates discussed above, particularly allodynia, duration of headache, and use of medication prior to ED presentation. Briefly, evidence of confounding will be sought by looking for an association between the heterogeneous variable and both the independent (study medication) and dependent (pain status) variables. Between-group differences will be expressed as means or proportions, bounded by 95% confidence intervals (95% CI). References: 1. Vinson DR. Treatment patterns of isolated benign headache in US emergency departments. Ann Emerg Med 2002; 39:215-22. 2. Bigal M, Bordini CA, Speciali JG. Headache in an emergency room in Brazil. Sao Paulo Med J 2000; 118:58-62. 3. Luda E, Comitangelo R, Sicuro L. The symptom of headache in emergency departments. The experience of a neurology emergency department. Ital J Neurol Sci 1995; 16:295-301. 4. Akpunonu BE, Mutgi AB, Federman DJ, et al. Subcutaneous sumatriptan for treatment of acute migraine in patients admitted to the emergency department: a multicenter study. Ann Emerg Med 1995; 25:464-9. 5. Bigal ME, Bordini CA, Speciali JG. Intravenous chlorpromazine in the emergency department treatment of migraines: a randomized controlled trial. J Emerg Med 2002; 23:141-8. 6. Kelly AM, Ardagh M, Curry C, D'Antonio J, Zebic S. Intravenous chlorpromazine versus intramuscular sumatriptan for acute migraine. J Accid Emerg Med 1997; 14:209-11. 7. Friedman B, Corbo J, Lipton R, et al. Metoclopramide Versus Sumatriptan for the ED Treatment of Migraines. Neurology 2005. 8. Esteban-Morales A, Chavez PT, Martinez CGR, Zuniga AS. Respuesta clinica de metoclopramida en comparacion con sumatriptan en el tratamiento de ataques agudos de migrana. Revista de la Sanidad Militar Mexico 1999; 53:36-40. 9. Tek DS, McClellan DS, Olshaker JS, Allen CL, Arthur DC. A prospective, double-blind study of metoclopramide hydrochloride for the control of migraine in the emergency department. Ann Emerg Med 1990; 19:1083-7. 10. Silberstein SD, Young WB, Mendizabal JE, Rothrock JF, Alam AS. Acute migraine treatment with droperidol: A randomized, double-blind, placebo-controlled trial. Neurology 2003; 60:315-21. 11. Seim MB, March JA, Dunn KA. Intravenous ketorolac vs intravenous prochlorperazine for the treatment of migraine headaches. Acad Emerg Med 1998; 5:573-6. 12. Meredith JT, Wait S, Brewer KL. A prospective double-blind study of nasal sumatriptan versus IV ketorolac in migraine. Am J Emerg Med 2003; 21:173-5. 13. Winner P, Ricalde O, Le Force B, Saper J, Margul B. A double-blind study of subcutaneous dihydroergotamine vs subcutaneous sumatriptan in the treatment of acute migraine. Arch Neurol 1996; 53:180-4. 14. Ellis GL, Delaney J, DeHart DA, Owens A. The efficacy of metoclopramide in the treatment of migraine headache. Ann Emerg Med 1993; 22:191-5. 15. Goadsby PJ, Lipton RB, Ferrari MD. Migraine--current understanding and treatment. N Engl J Med 2002; 346:257-70. 16. Ducharme J, Beveridge RC, Lee JS, Beaulieu S. Emergency management of migraine: is the headache really over? Acad Emerg Med 1998; 5:899-905. 17. Hardman J, Limbird L. Goodman and Gilman's the pharmacological basis of therapeutics, 9th ed. New York: McGraw-Hill, Health Professions Division, 1996. 18. Lipton RB, Hamelsky SW, Dayno JM. What do patients with migraine want from acute migraine treatment? Headache 2002; 42 Suppl 1:3-9. 19. Krymchantowski AV, Barbosa JS. Dexamethasone decreases migraine recurrence observed after treatment with a triptan combined with a nonsteroidal anti-inflammatory drug. Arq Neuropsiquiatr 2001; 59:708-11. 20. Innes G, Macphail I, Dillon E. Dexamethasone prevents relapse after emergency department treatment of acute migraine: a randomized clinical trial. Canadian Journal of Emergency Medicine 1999; 1. 21. Gallagher RM. Emergency treatment of intractable migraine. Headache 1986; 26:74-5. 22. Monzillo P, Nemoto P, Costa A, Sanvito W. Tratamento Agudo Da Crise De Enxaqueca Refrataria Na Emergencia. Arq Neuropsiquiatr 2004; 62:513-518. 23. Corbo J, Esses D, Bijur PE, Iannaccone R, Gallagher EJ. Randomized clinical trial of intravenous magnesium sulfate as an adjunctive medication for emergency department treatment of migraine headache. Ann Emerg Med 2001; 38:621-7. 24. Cameron JD, Lane PL, Speechley M. Intravenous chlorpromazine vs intravenous metoclopramide in acute migraine headache. Acad Emerg Med 1995; 2:597-602. 25. Tfelt-Hansen P, Block G, Dahlof C, et al. Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia 2000; 20:765-86. 26. Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain. Headache Classification Committee of the International Headache Society. Cephalalgia 1988; 8 Suppl 7:1-96. 27. Lipton RB, Cady RK, Stewart WF, Wilks K, Hall C. Diagnostic lessons from the spectrum study. Neurology 2002; 58:S27-31. 28. Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med 2003; 10:390-2. 29. Kelly AM. Migraine: pharmacotherapy in the emergency department. J Accid Emerg Med 2000; 17:241-5. 30. Friedman BW, Corbo J, Lipton RB, et al. A trial of metoclopramide vs sumatriptan for the emergency department treatment of migraines. Neurology 2005; 64:463-8. 31. Drug Consult. St. Louis: Mosby, Inc., 2005. 32. Swidan SZ, Lake AE, 3rd, Saper JR. Efficacy of intravenous diphenhydramine versus intravenous DHE-45 in the treatment of severe migraine headache. Curr Pain Headache Rep 2005; 9:65-70. 33. O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979; 35:549-56. 34. Burstein R, Collins B, Jakubowski M. Defeating migraine pain with triptans: a race against the development of cutaneous allodynia. Ann Neurol 2004; 55:19-26. 35. Ashkenazi A, Sholtzow M, Young WB. Prevalence of Dynamic Mechanical (Brush) Allodynia in MIgraine (Abstract). Neurology 2004; 62:A83.

Migraine

migraine, emergency department, dexamethasone Migraine with or without aura or probable migraine without aura as defined by ICHD, 2nd edition

null

2

arm 1: Dexamethasone 10 mg arm 2: Placebo Dexamethasone, 10 mg

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: Dexamethasone 10mg IV intervention 2: Placebo Dexamethasone 10mg IV

intervention 1: Dexamethasone intervention 2: Placebo

3

0

NCT00122278

[ 2, 3 ]

36

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to find the highest safe dose and to assess the anti-tumor effect of liposomal vincristine with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).

OBJECTIVES: * Determine the maximum tolerated dose (MTD) of liposomal vincristine given with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL). * Determine the efficacy of liposomal vincristine given with dexamethasone in these patients.

Acute Lymphoblastic Leukemia

null

1

arm 1: Vincristine Sulfate Liposomes Injection (VSLI)

[ 0 ]

2

[ 0, 0 ]

intervention 1: Study treatment consists of infusion of VSLI intravenously over 60 minutes on Day 1 and Days 8, 15 and 22 (+/- 2 days). intervention 2: Study treatment consists of 40 mg dexamethasone, daily orally or intravenously, on Days 1-4 (+/- 2 days) and Days 11-14 (+/- 2 days).

intervention 1: Vincristine Sulfate Liposomes Injection intervention 2: Dexamethasone

3

0

NCT00144963

[ 5 ]

500

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.

This trial will attempt to investigate whether asthmatic patients that are well controlled with low-dose twice daily inhaled corticosteroid (ICS) therapy can safely be switched to other modes of controller therapy without loss of asthma control. Patients demonstrating good control on twice-daily low-dose ICS will be randomized to one of three treatment groups: once-daily low-dose ICS (fluticasone), leukotriene receptor antagonist (montelukast), or once-daily combination therapy (fluticasone-salmeterol).

Asthma

Asthma Asthma Control

null

3

arm 1: Participants continued fluticasone (100 microgram twice daily) treatment. arm 2: Participants were changed to Montelukast (5 or 10 mg each night). arm 3: Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.

[ 1, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: fluticasone (100 microgram twice daily) treatment intervention 2: Montelukast (5 or 10 mg each night). intervention 3: fluticasone (100 microgram) plus salmeterol (50 microgram) each night

intervention 1: fluticasone intervention 2: montelukast intervention 3: Fluticasone plus salmeterol

19

0

NCT00156819

[ 3 ]

249

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of the study is to evaluate the effectiveness and safety of CNTO 1275 in patients with Multiple Sclerosis

Multiple sclerosis (MS) is a life-long disease that usually starts in young adults. In MS, inflammation and damage to nerve cells occur in the brain and spinal cord. Symptoms of MS are quite variable and may range from being mild to severe and from short to long lasting. People with MS may have a wide variety of symptoms ranging from mild to disabling. Some of thesymptoms of MS include visual disturbances such as double vision, weakness in arms or legs,difficulty with coordination, fatigue, changes in sensations such as numbness and tingling, or difficulties with concentration or memory.The drug being tested in this research study is an antibody called CNTO 1275. Antibodies are natural substances made by the body that stick to and react with other substances in the body that may cause diseases. The body makes antibodies mainly to fight infections. CNTO 1275 is an antibody that has been manufactured in the laboratory. In the test tube, CNTO 1275 sticks to and blocks the activity of a naturally occurring substance in the body called interleukin 12 (IL-12).Higher than normal levels of IL-12 have been found in people who have MS. CNTO 1275 has been tested in animals with a condition similar to MS. In those animals, IL-12 was over-produced.Animals treated with CNTO 1275 showed decreased symptoms of the condition.The purpose of this study is to better understand the safety and effectiveness of CNTO 1275 in people who have relapsing-remitting MS Patients will receive subcutaneous injections of 30, 100, 200 mg of CNTO 1275 or placebo at Weeks 0, 1, 2, 3, 7, 11, 15, and 19 or 100 mgs at weeks 0,1,2,3,11 and 19 and placebo at wks 7 and 15.

Multiple Sclerosis

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: CNTO 1275

0

null

0

NCT00207727

[ 0 ]

34

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to evaluate the safety and efficacy of the Alair System for the treatment of severe refractory asthma. This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy in patients with severe asthma refractory to standard medication therapy. A total of 30 subjects will be randomized 1:1 to the Alair Group (Medical management + Alair Treatment) OR the Control Group (Medical management only).

Multicenter, randomized, clinical trial conducted at 8 Investigational Sites in 3 countries. Subjects in the Alair group to be administered the Alair treatment in 3 separate bronchoscopy sessions, while subjects in the Control group will complete 3 "Control Visits" to the Physicians office, timed to coincide with the 3 treatment bronchoscopy sessions. Following completion of all three procedures or Control Visits subjects will be evaluated at 6 weeks and 12 weeks. All subjects to remain on their maintenance asthma medications until they are evaluated again at 22 weeks after the last procedure or Control Visit. This phase from the last procedure or Control Visit out to 22 Weeks after the last procedure or Control Visit is termed the Steroid Stable Phase. Subjects will undergo a 14 week period from 22 Weeks to 36 Weeks (termed the Steroid Wean Phase) during which an attempt will be made to wean them off either their maintenance inhaled corticosteroids (ICS) or, if taking maintenance oral corticosteroids (OCS), their oral steroids. If a subject cannot tolerate the steroid reduction at a particular level (as evidenced by loss of asthma control), they will be stabilized on their last tolerable dose of steroid. All subjects will maintain their reduced steroid dosage from the end of the Steroid Wean Phase at 36 weeks to their final evaluations at the end of the Study at 52 weeks (termed the Reduced Steroid Phase). All subjects will be exited from the study following completion of the 52 week evaluations.

Asthma

Asthma Bronchial Thermoplasty

null

2

arm 1: Alair treatment plus standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤ 30 mg/day. arm 2: Standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤30 mg/day.

[ 0, 1 ]

2

[ 3, 0 ]

intervention 1: Alair treatment plus standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤ 30 mg/day. intervention 2: Standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤30 mg/day.

intervention 1: Bronchial Thermoplasty with the Alair System intervention 2: Control

0

null

0

NCT00214539

[ 4 ]

461

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

2MALE

false

A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Benign Prostatic Hyperplasia (BPH)

Benign prostatic hyperplasia, BPH, alpha blocker

null

2

arm 1: Silodosin 8 mg once daily with food arm 2: Matching Placebo capsule once daily with food

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: 8 mg daily for 12 weeks intervention 2: 1 capsule daily for 12 weeks

intervention 1: Silodosin intervention 2: Placebo

43

0

NCT00224107

[ 3 ]

48

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

2MALE

null

To evaluate inter-ethnic similarity in pharmacodynamics between Japanese and Caucasian healthy adult male subjects by comparing electrophysiological reactions after administering E2014 to extensor digitorum brevis muscle (EDB).

null

Spasmodic Torticollis

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: A single-dose injection solution containing 20 units (U), 100 U, or 500 U/ 0.2 milliliters (mL) of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese and Caucasian participants. Duration of treatment lasted for 12 weeks: from Day -1 to Week 12. Participants were hospitalized from a day before study treatment to Day 8 for 9 nights and 10 days, and visited at the medical institution on Days 10 and 14, and Weeks 4 and 12. intervention 2: A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese and Caucasian participants. Duration of treatment lasted for 12 weeks: from Day -1 to Week 12. Participants were hospitalized from a day before study treatment to Day 8 for 9 nights and 10 days, and visited at the medical institution on Days 10 and 14, and Weeks 4 and 12.

intervention 1: E2014 (Botulinum toxin type B) intervention 2: E2014 (Botulinum toxin type B) Placebo

1

Kagoshima | Kagoshima-ken | Japan | 130.55 | 31.56667

0

NCT00280384

[ 4 ]

411

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

true

0ALL

false

The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.

null

Insomnia

null

4

arm 1: Take orally 30 minutes prior to bedtime. arm 2: 20 mg taken orally 30 minutes prior to bedtime. arm 3: 50 mg taken orally 30 minutes prior to bedtime. arm 4: 100 mg taken orally 30 minutes prior to bedtime.

[ 2, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 20 mg VEC-162 intervention 2: 50 mg VEC-162 intervention 3: 100 mg VEC-162 intervention 4: Placebo

19

0

NCT00291187

[ 0 ]

16

RANDOMIZED

SINGLE_GROUP

0TREATMENT

2DOUBLE

true

0ALL

false

The objective of this study is to assess the comparative utility of topical formulations in hastening the resolution of skin bruising. For each subject, four standard bruises of 7 mm diameter each were created on the bilateral upper inner arms, 5 cm apart, two per arm, using a 595-nm pulsed-dye laser. Randomization was used to assign one topical agent (5% vitamin K, 1% vitamin K and 0.3% retinol, 20% arnica or white petrolatum) to exactly one bruise per subject, which was then treated under occlusion twice a day for 2 weeks. A dermatologist rated bruises in standardized photographs immediately after bruise creation and at week 2.

null

Ecchymosis

Bruising Topical 20% arnica

null

1

arm 1: Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.

[ 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Topical formation applied to bruise twice daily for 2 weeks. intervention 2: Topical formation applied to bruise twice daily for 2 weeks. intervention 3: Topical formation applied to bruise twice daily for 2 weeks. intervention 4: Topical formation applied to bruise twice daily for 2 weeks.

intervention 1: Petrolatum United States Pharmacopeia (USP) intervention 2: Vitamin K and retinol ointment intervention 3: Arnica ointment intervention 4: Vitamin K ointment

1

Chicago | Illinois | United States | -87.65005 | 41.85003

0

NCT00363038

[ 3 ]

5

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This Phase 2 study was designed to assess the safety and hematological activity of AMD3100 (plerixafor) in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2\*10\^6 CD34+ cells/kg within 3 apheresis days. Patients with NHL and MM were eligible to enter the study if they had undergone cyto-reductive chemotherapy, were to undergo autologous transplantation, and met the inclusion/exclusion criteria. The purpose of this protocol was to determine whether plerixafor in combination with Granulocyte Colony Stimulating Factor (G-CSF) can increase the circulating levels of peripheral blood stem cells (PBSCs) in patients whose peripheral CD34+ counts remain low after treatment with G-CSF alone, whether it was safe, and whether transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).

A Phase 2, single-center, open-label study to assess the safety and hematological activity of plerixafor in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2\*10\^6 CD34+ cells/kg within 3 apheresis days. The only change to the standard of care was the addition of plerixafor to a G-CSF mobilization regimen on the day prior to apheresis. Following screening procedures, eligible patients undergo mobilization with G-CSF (10 µg/kg every day) for 5 days and their peripheral blood (PB) CD34+ cell count was measured on the fifth day. On Day 5, if the patient's peripheral CD34+ cell count was \<5 cells/µl or ≥20 cells/µl, the patient did not enter this study and was treated as per the policy of the study site. On Day 5, if the patient's peripheral CD34+ cell count was 5 to 7 cells/µl (inclusive), the patient did not undergo apheresis that day, but did receive plerixafor (240 µg/kg) that evening and G-CSF followed by apheresis the next morning. The evening dose of plerixafor followed the next morning by G-CSF and apheresis was repeated for up to a total of 3 days of apheresis or until ≥5\*10\^6 cells/kg are collected. On Day 5, if the patient's peripheral CD34+ cell count was 8 to 19 cells/µl (inclusive), then he/she underwent apheresis that day. If this apheresis yield was \<1.3\*10\^6 CD34+ cells/kg, then the patient was predicted to be unlikely to collect ≥2\*10\^6 CD34+ cells/kg in ≥3 days of apheresis and received plerixafor (240 µg/kg) that evening. However, if the apheresis yield on Day 5 was ≥1.3\*10\^6 CD34+ cells/kg, then the patient did not enter the study. The next morning (Day 6), eligible patients received G-CSF (10 µg/kg) and began apheresis approximately 10 to 11 hours after the previous evening plerixafor dose. If the apheresis yield was at least double the apheresis yield on Day 5, then the patient received another 10:00 pm dose of plerixafor and underwent apheresis again the next morning (Day 7) after receiving G-CSF. The evening dose of plerixafor followed the next morning by G-CSF and apheresis was repeated for up to a total of 3 days of apheresis or until ≥5\*10\^6 cells/kg were collected. All patients, after the completion of apheresis procedures (or after ≥5\*10\^6 cells/kg were collected), received high-dose chemotherapy in preparation for transplantation. Patients were transplanted with cells collected after receiving plerixafor with G-CSF. However, if there were insufficient cells, cells collected after receiving plerixafor with G-CSF could be pooled with cells collected after receiving G-CSF alone. Hematological activity of plerixafor was evaluated by assessing the number of CD34+ cells harvested during apheresis. This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Multiple Myeloma Lymphoma, Non-Hodgkin's

Non-Hodgkin's Lymphoma Multiple Myeloma stem cell mobilization autologous transplantation AMD3100

null

1

arm 1: Patients who were predicted to be unable to mobilize a minimum number of cells (≥2\*10\^6 CD34+ cells/kg) in 3 apheresis days when given granulocyte colony-stimulating factor (G-CSF) alone and who were eligible for autologous peripheral blood stem cell transplantation.

[ 0 ]

1

[ 0 ]

intervention 1: Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.

intervention 1: G-CSF plus plerixafor

1

Durham | North Carolina | United States | -78.89862 | 35.99403

0

NCT00395967

[ 5 ]

1

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

false

The purpose of this study is to evaluate the cardiac safety of Caelyx in patients with metastatic breast cancer who have previously received chemotherapy with anthracyclines.

null

Breast Neoplasm

null

1

arm 1: Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles

[ 0 ]

1

[ 0 ]

intervention 1: Pegylated Liposomal Doxorubicin (Caelyx) IV, 50 mg/m2 once every 4 weeks for 6 cycles or until disease progression, whichever is earlier. Patients still receiving clinical benefit after a total of 6 cycles of Caelyx, may continue therapy at the discretion of the investigator.

intervention 1: Pegylated Liposomal Doxorubicin

0

null

0

NCT00779285

[ 2 ]

32

RANDOMIZED

CROSSOVER

null

0NONE

true

1FEMALE

false

This study was designed to compare the relative bioavailability (rate and extent of absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablet) in healthy, adult subjects administered under fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Healthy

Bioequivalence Healthy Subjects

null

2

arm 1: Drospirenone/Ethinyl Estradiol Tablets, 3 mg/0.02 mg arm 2: YAZ® Tablets, 3 mg/0.02 mg

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 3 mg/0.02 mg Tablets intervention 2: 3 mg/0.02 mg Tablets

intervention 1: Drospirenone/Ethinyl Estradiol (Gianvi®) intervention 2: YAZ®

1

Fargo | North Dakota | United States | -96.7898 | 46.87719

0

NCT01182194

[ 2 ]

33

RANDOMIZED

CROSSOVER

null

0NONE

true

1FEMALE

false

This study was designed to compare the relative bioavailability (rate and extent of absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablets) in healthy, adult subjects under non-fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Healthy

Bioequivalence Healthy Subjects

null

2

arm 1: Drospirenone/Ethinyl Estradiol Tablets, 3 mg/0.02 mg arm 2: YAZ® Tablets, 3 mg/0.02 mg

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 3 mg/0.02 mg Tablets intervention 2: 3 mg/0.02 mg Tablets

intervention 1: Drospirenone/Ethinyl Estradiol (Gianvi®) intervention 2: YAZ®

1

Fargo | North Dakota | United States | -96.7898 | 46.87719

0

NCT01182207

[ 0 ]

529

RANDOMIZED

PARALLEL

null

0NONE

false

0ALL

null

The purpose of this study is to evaluate the effects on blood pressure control, pulse wave velocity, as well as safety and tolerability of felodipine single or combine with other drugs in Chinese Hypertension patients.

In this study, investigators will choose male and female subjects aged between 35 and 79 years old with mild to moderate essential hypertension. At first 2 weeks, all patients will use felodipine 5mg daily. If the blood pressure dosen't meet the target (140/90mmHg), they will be randomized into metoprolol, lisinopril or hydrochlorothiazide combination groups for another 4 weeks therapy. After that, if the blood pressure has still not met the target, up-titrate the felodipine into 10mg, followed by a 4 weeks therapy. And if the blood pressure is still not met the target after that, up-titrate the combine drugs into maximum dosage. The whole treatment duration is 14 weeks. The primary outcome is to evaluate the percentage of subjects reaching blood pressure target (defined as \< 140 / 90 mmHg) after 14 weeks treatment with felodipine sustained release in combination with metoprolol, lisinopril or hydrochlorothiazide.

Hypertension

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 0, 1, 1, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Felodipine sustained release tablet single drug therapy (1st week- 2nd week) Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks. If blood pressure is controlled after 2 weeks, then the subjects will continue the treatment until the end of primary therapy stage (14th week). intervention 2: Step 1: Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks. If blood pressure is not controlled after 2 weeks, then the subjects will go to Step 2: Felodipine sustained release tablet 5mg once daily combined with hydrochlorothiazide 12.5mg, once daily. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 3: The dosage of felodipine sustained release tablet will be escalated to 10mg, once daily, while the dosage of the combined drug remains the same. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 4: The dosage of felodipine sustained release tablet keeps 10mg, once daily, while the dosage of different combined drug is doubled. intervention 3: Step 1: Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks. If blood pressure is not controlled after 2 weeks, then the subjects will go to Step 2: Felodipine sustained release tablet 5mg once daily combined with metoprolol succinate prolonged-release tablet (Betaloc ZOK) 47.5mg , once daily. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 3: The dosage of felodipine sustained release tablet will be escalated to 10mg, once daily, while the dosage of the combined drug remains the same. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 4: The dosage of felodipine sustained release tablet keeps 10mg, once daily, while the dosage of different combined drug is doubled. intervention 4: Step 1: Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks. If blood pressure is not controlled after 2 weeks, then the subjects will go to Step 2: Felodipine sustained release tablet 5mg once daily combined with Lisinopril (Zestril) 10mg, once daily. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 3: The dosage of felodipine sustained release tablet will be escalated to 10mg, once daily, while the dosage of the combined drug remains the same. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 4: The dosage of felodipine sustained release tablet keeps 10mg, once daily, while the dosage of different combined drug is doubled.

intervention 1: Felodipine tablet (Plendil) alone intervention 2: Felodipine tablet (Plendil)+Hydrochlorothiazide intervention 3: Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK) intervention 4: Felodipine tablets (Plendil)+Lisinopril (Zestril)

0

null

0

NCT02336607

[ 4 ]

75

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study will be conducted to collect cases treated by self-injection of sumatriptan 3mg kit product for the treatment of migraine or cluster headache attacks in clinical settings, to demonstrate the efficacy, and to examine patient acceptability (simplicity and usefulness) and rate of successful self-injection.

null

Migraine Disorders

Migraine Sumatriptan Succinate Injection Kit Cluster Headache self-injection

null

1

arm 1: Sumatriptan

[ 0 ]

1

[ 0 ]

intervention 1: Sumatriptan Succinate

4

Aichi | N/A | Japan | 130.62158 | 32.51879 Hyōgo | N/A | Japan | 144.43333 | 43.36667 Kyoto | N/A | Japan | 135.75385 | 35.02107 Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00356603

[ 3 ]

50

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this research study is to find how breast cancer responds to the investigational drug, Ispinesib. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. In particular, this study will try is to find the answers to the following research questions: 1. Does breast cancer respond to Ispinesib? 2. What are the side effects of Ispinesib? 3. How much Ispinesib is in the blood at specific times after it is taken?

null

Neoplasms, Breast

breast cancer

null

1

arm 1: Females with advanced or metastatic breast cancer were administered Ispinesib

[ 0 ]

1

[ 0 ]

intervention 1: Given intravenously at a dose of 18 milligram (mg)/ meter square (m\^2).

intervention 1: Ispinesib

13

0

NCT00089973

[ 3 ]

100

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

The objective of the trial was to establish the dose-response relation of sugammadex (Org 25969) given as a reversal agent of rocuronium or vecuronium at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1) during sevoflurane anesthesia for Caucasian participants.

For most surgical procedures a depth of neuromuscular block of 1-2 twitches after TOF-stimulation is sufficient to avoid unwanted muscular activity. At reappearance of T2, the anesthesiologist might decide to either give (another) maintenance dose of rocuronium or vecuronium when surgery continues, to await spontaneous recovery of neuromuscular block or to reverse the neuromuscular block. Sugammadex has been shown in previous trials to greatly reduce the time to full recovery when administered at reappearance of T2, both after rocuronium- and vecuronium induced neuromuscular blockade. The current trial P05971 was conducted in Europe and set up to establish the dose response relationship of sugammadex given during sevoflurane anesthesia at reappearance of T2 after rocuronium or vecuronium in Caucasian participants. In addition to recovery time, also pharmacokinetics and safety of sugammadex were to be evaluated.

Anesthesia, General

null

10

arm 1: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV. arm 2: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV. arm 3: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV. arm 4: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV. arm 5: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV. arm 6: After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV. arm 7: After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV. arm 8: After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV. arm 9: After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV. arm 10: After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.

[ 2, 0, 0, 0, 0, 2, 0, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered intervention 2: After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arm 1) or 0.1 mg/kg vecuronium (arm 6). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of Placebo IV was administered intervention 3: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary. intervention 4: After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV. Maintenance doses of 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.

intervention 1: Sugammadex intervention 2: Placebo intervention 3: Rocuronium intervention 4: Vecuronium

0

null

0

NCT00552617

[ 3 ]

961

RANDOMIZED

SINGLE_GROUP

1PREVENTION

2DOUBLE

false

0ALL

false

Odiparcil is being studied to determine if it can prevent blood clots from forming after a total knee replacement and also to prove that odiparcil is safe.

null

Deep Vein Thrombosis Fibrillation, Atrial Venous Thromboembolism Pulmonary Embolism

deep vein thrombosis total knee replacement PE Venous thromboembolism DVT pulmonary embolism VTE

null

0

null

3

[ 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None

intervention 1: Odiparcil intervention 2: Warfarin intervention 3: Coumadin

101

1

NCT00244725

[ 2 ]

19

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of benzoylphenylurea in treating patients who have advanced solid tumors.

OBJECTIVES: * Determine the maximum tolerated dose of benzoylphenylurea in patients with advanced solid tumors. * Evaluate the acute and chronic toxicity profile of this regimen in these patients. * Evaluate the pharmacokinetics and metabolites of this regimen and any potential correlation with pharmacodynamic effects in these patients. * Determine the antitumor activity of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral benzoylphenylurea (BPU) once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BPU until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity. Once the MTD is determined, 12 additional patients are accrued and treated with BPU as above to confirm the MTD. Patients are followed for 30 days. PROJECTED ACCRUAL: Approximately 18-24 patients will be accrued for this study.

Unspecified Adult Solid Tumor, Protocol Specific

unspecified adult solid tumor, protocol specific

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: benzoylphenylurea

1

Baltimore | Maryland | United States | -76.61219 | 39.29038

0

NCT00016354

[ 3 ]

9

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to look at the safety and effectiveness of ONTAK in previously treated patients with NHL.

null

Non-Hodgkin's Lymphoma Lymphoma, B-cell Lymphoma, Low-grade

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: ONTAK

2

0

NCT00051025

[ 4 ]

211

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).

Patients with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called PA. Treatment with antibiotics can stop or slow down the growth of the bacteria. The antibiotics may be given by mouth, intravenously (IV), or by inhalation as a mist. The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI), an investigational formulation of the antibiotic administered using the eFlow® Electronic Nebulizer by PARI GmbH, in CF patients with PA. In this study, participants were screened for eligibility at Visit 1 (Day -42) and returned to the center for Visit 2 after a 14-day evaluation period. At Visit 2 (Day -28), participants began a 28-day course of open-label Tobramycin Inhalation Solution (TIS). At Visit 3 (Day 0), following completion of the 28-day course of TIS, participants began randomized, blinded treatment with either AZLI twice a day (BID) or three times a day (TID) or placebo BID or TID, and continued treatment for a total of 28 days, with a clinic visit at Day 14 (Visit 4) and at the end of treatment (Visit 5 \[Day 28\]). Participants returned for visits every 2 weeks for 8 weeks after the end of the blinded treatment (Visits 6 to 9 \[Days 42 to 84\]). Two hundred and forty-seven participants were treated in the TIS phase of this study. Two hundred and eleven subjects completed the TIS phase and were treated in the placebo-controlled phase with study drug (AZLI or placebo).

Cystic Fibrosis

Cystic Fibrosis Pseudomonas aeruginosa Pulmonary Cystic Fibrosis

null

2

arm 1: None arm 2: None

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: AZLI 75 mg two times a day (BID)/three times a day (TID) intervention 2: Placebo two times a day (BID)/three times a day (TID)

56

0

NCT00104520

[ 4 ]

61

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will treat hemodialysis patients who have a central catheter that is thought to be infected with a specific bacteria (Gram positive bacteria).

Pfizer suspended enrollment on 21 August 2006 as a precautionary measure in light of the mortality imbalance seen in a similar study, and terminated the study on April 6, 2007 due to factors affecting the timeline to completion, such as slow enrollment and inclusion of sufficient evaluable subjects.

Bacteremia Gram-Positive Bacterial Infections

null

0

null

3

[ 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None

intervention 1: Cefazolin IV intervention 2: Linezolid IV intervention 3: Vancomycin (IV)

17

0

NCT00108433

[ 4 ]

300

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.

Multiple sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result, patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR is an experimental drug that has been reported to possibly improve muscle strength and walking ability for some people with MS. This study will evaluate the effects and possible risks of taking Fampridine-SR in subjects with MS.

Multiple Sclerosis

Walking Ability

null

2

arm 1: Placebo control arm 2: 10 milligram (mg) tablet b.i.d.

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: Tablets, 10 mg, twice daily, 14 weeks intervention 2: sugar pill, twice a day (b.i.d.)

intervention 1: Fampridine-SR intervention 2: Placebo

34

0

NCT00127530

[ 3 ]

75

RANDOMIZED

PARALLEL

null

2DOUBLE

false

0ALL

null

This is a randomized, double-blind, two treatment, two group, parallel group study. Subjects will be randomized to one of two treatment groups (E2007 or Placebo) in a 3 to 1 ratio and receive treatment for a total of ten weeks (Days 1 to 70).

null

Parkinson's Disease

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: E2007

10

0

NCT00165789

[ 5 ]

107

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This study will compare employment support with behavioral skills training to employment support alone in schizophrenia patients taking either risperidone or olanzapine to determine which is more effective in helping the patients maintain a job.

Schizophrenia is a severe mental disorder characterized by disorganized thoughts, difficulty concentrating, and hallucinations. Individuals with schizophrenia often experience reduced emotional, social, and occupational functioning. Data indicate that antipsychotic drug treatment and occupational training and support may be effective in helping people with schizophrenia maintain a stable job. Risperidone and olanzapine are antipsychotic drugs; participants in this study will be taking either risperidone or olanzapine for the duration of the study. This study will provide schizophrenia patients with employment support alone or with behavioral skills training to determine which combination is more effective in helping patients obtain and maintain a job. At study entry, participants will undergo a clinical and diagnostic evaluation to determine the severity of their schizophrenia. Participants will be tapered off their regular medication for schizophrenia over 4 weeks. At the end of Week 4, they will be randomly assigned to receive either risperidone or olanzapine. Participants will then be assigned an Individual Placement and Support (IPS) specialist to assist them in finding a job. After participants secure a job, they will be randomly assigned to receive IPS either alone or with the Workplace Fundamentals Skills Training Module for 2 years. Participants' risperidone or olanzapine treatment will continue during this 2-year period. Participants will have clinic visits at study entry and Months 7, 12, and 24. At each visit, participants will complete questionnaires and will be interviewed about their schizophrenia symptoms and occupational functioning.

Schizophrenia

Antipsychotic Agents Employment

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 1, 1, 1, 1 ]

4

[ 5, 5, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None intervention 4: None

intervention 1: Individual Placement and Support (Supported Employment) intervention 2: Social Skills Training intervention 3: Olanzapine intervention 4: Risperidone

2

0

NCT00183625

[ 4 ]

31

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This study will determine the efficacy and safety of combination therapy with divalproex and lithium for treating mania in people with rapid cycling bipolar disorder and a substance abuse disorder.

Longitudinal Evaluation of the Efficacy and Safety of Divalproex and Lithium in Dual Diagnosis Bipolar Rapid Cycling: This study recruits males and females age 18 and older who currently meet diagnostic criteria for rapid cycling bipolar disorder (type I or II) and who have met the criteria for substance abuse or dependence of cocaine, marijuana and/or alcohol within the past six months. Patients are initially stabilized on dual therapy of lithium and depakote and then randomly assigned to double-blind treatment with either lithium monotherapy or continued dual therapy. Patients remain in the study for six months or until they experience a relapse. Patients in this study are required to bring a friend or family member to all study visits as well as attend chemical dependency services. This study is sponsored by the NIMH. Subjects receive study-related care at no cost.

Bipolar Disorder

null

2

arm 1: Patients assigned to the combination group were continued on lithium and blinded divalproex. arm 2: Patients assigned to lithium monotherapy underwent divalproex-placebo substitution at a rate of 250 mg decrements every week until discontinued.

[ 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L. intervention 2: Divalproex was then initiated at 250 mg twice daily and increased over 3-6 weeks to minimum blood levels of 50 ug/ml. intervention 3: Placebo pills that looked exact to divaloproex were provided to subjects and take twice daily.

intervention 1: Lithium intervention 2: Divalproex intervention 3: Placebo

1

Cleveland | Ohio | United States | -81.69541 | 41.4995

0

NCT00194129

[ 4 ]

47

RANDOMIZED

CROSSOVER

1PREVENTION

2DOUBLE

false

0ALL

false

To determine the effect of an approved medication being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also known as exercise-induced bronchospasm), in patients who have a history of worsening asthma after exercise.

null

Asthma, Exercise-Induced

null

6

arm 1: Montelukast - Salmeterol - Placebo arm 2: Montelukast - Placebo - Salmeterol arm 3: Salmeterol - Montelukast - Placebo arm 4: Salmeterol - Placebo - Montelukast arm 5: Placebo - Montelukast - Salmeterol arm 6: Placebo - Salmeterol - Montelukast

[ 0, 0, 0, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 1 dose montelukast 10 mg tablet given orally in one of three treatment periods intervention 2: 1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods intervention 3: 1 dose matching-image placebo to montelukast tablet in two of three treatment periods intervention 4: 1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods

intervention 1: Comparator: Montelukast intervention 2: Comparator: Salmeterol intervention 3: Comparator: Placebo (montelukast) intervention 4: Comparator: Placebo (salmeterol)

0

null

0

NCT00245570

[ 4 ]

116

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.

null

Cervical Dystonia

null

2

arm 1: Drug: abobotulinumtoxinA (Dysport®) arm 2: Placebo

[ 0, 2 ]

2

[ 2, 0 ]

intervention 1: 500 units intervention 2: 500 units

intervention 1: Botulinum toxin type A intervention 2: Placebo

22

0

NCT00257660

[ 3 ]

34

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

null

The purpose of the study is to evaluate the efficacy of an anti-psychotic medication, Olanzapine, in achieving desired weight gain in patients identified as having Anorexia Nervosa, either restricting or binge/purge subtype. The study will also evaluate the possible beneficial effects of Olanzapine in reducing the severity of the obsessive and/or anxiety symptoms associated with this disorder.

Anorexia Nervosa

Pilot Project, Clinical Trial, Treatment Outcome, Psychopharmacology

null

2

arm 1: Placebo and Treatment as usual (Day Hospital Program). After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy. arm 2: After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.

[ 2, 0 ]

2

[ 0, 5 ]

intervention 1: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day. intervention 2: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.

intervention 1: Olanzapine intervention 2: Day Hospital

1

Ottawa | Ontario | Canada | -75.69812 | 45.41117

0

NCT00260962

[ 0 ]

30

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

0ALL

false

Trauma patients are at increased risk for adrenal function insufficiency. A commonly used agent for rapid sequence intubation (RSI) is known to decrease adrenal function. We want to determine the incidence of adrenocortical insufficiency and its significance during the first 24 hours of resuscitation following RSI in trauma patients.

The study will have two arms. Patients on one arm will be assigned to receive etomidate (0.3 mg/kg) and succinylcholine (1mg/kg) for RSI. Patients on the other arm will receive standard therapy at this institution which consists of Versed (generic name midazolam) (5 mg) plus fentanyl (100 mcgs) as well as succinylcholine for RSI. Both drug regimens have a rapid onset, short duration and short half-life. Patients will be randomly assigned to one arm of the study. The trauma nurse emergency room responders, intensive care unit staff, or helicopter crew will pull a study envelope which will contain a randomization to either the etomidate arm or standard therapy arm. The numbers will correspond to a log, delineating which medication is given. The nurse will document the medication as RSI Study Drug - etomidate or RSI Study Drug - standard and the randomization packet number (ie, RSI Study Drug, etomidate, #1, RSI Study Drug, standard, #2, etc.) and will document the patient's name and medical record number on the study log in either the helicopter or the ER Resuscitation Bay. Baseline cortisol level will be drawn prior to RSI. An additional cortisol level will be drawn 4-6 hours later. Following this level, a cortrosyn stimulation test will be performed by giving 0.25 mg cortrosyn IV and rechecking a cortisol level in 60 minutes. Adrenal insufficiency will be defined as a baseline cortisol level of \<15 or an increase in cortisol of \<9 after cortrosyn administration. Patients will be monitored for 24 hours for hemodynamics, IV fluid administration , and use of vasopressors. Patient will be resuscitated to adequate mean arterial blood pressure and urine output. Any patient found to be adrenal insufficient will be treated with hydrocortisone 50 mg IV every 6 hours.

Adrenal Insufficiency

adrenal insufficiency etomidate rapid sequence induction

null

2

arm 1: Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications arm 2: Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: etomidate 0.3 mg/kg IV plus succinylcholine 1 mg/kg IV intervention 2: 100 micrograms fentanyl IV, plus 5 mg midazolam IV, plus 1 mg/kg succinylcholine IV

intervention 1: RSI sedation with etomidate/succinylcholine intervention 2: RSI sedation with fentanyl/midazolam/succinylcholine

1

Chattanooga | Tennessee | United States | -85.30968 | 35.04563

0

NCT00462644

[ 4 ]

5

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

Purpose of the study is to compare the effects of megestrol acetate concentrated suspension and placebo on caloric intake for the treatment of cancer-associated anorexia in patients with lung or pancreatic cancer

null

Anorexia Cachexia Weight Loss

Megestrol acetate Anorexia Cachexia Lung cancer Pancreatic cancer Unintended weight loss Body weight Appetite Megace ES

null

2

arm 1: Megestrol acetate concentrated suspension 110 mg/mL arm 2: Placebo suspension

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Megestrol acetate concentrated suspension 110 mg/mL given as an oral dose of 550 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase intervention 2: Placebo oral suspension, 5 mL once daily

intervention 1: Megestrol acetate concentrated suspension 110 mg/mL intervention 2: Placebo

3

0

NCT00637728

[ 4 ]

4

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia.

null

Anorexia Cachexia Weight Loss

Megestrol acetate Anorexia Cachexia Cancer Unintended weight loss Body weight Appetite Megace ES

null

3

arm 1: Megestrol acetate concentrated suspension 110 mg/mL arm 2: Megestrol acetate concentrated suspension 60 mg/mL arm 3: None

[ 1, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Megestrol acetate concentrated suspension 110 mg/mL given as an oral dose of 550 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase intervention 2: Megestrol acetate concentrated suspension 60 mg/mL given as an oral dose of 300 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase intervention 3: Placebo oral suspension, 5 mL once daily

intervention 1: Megestrol acetate concentrated suspension 110 mg/mL intervention 2: Megestrol acetate concentrated suspension 60 mg/mL intervention 3: Placebo

4

0

NCT00637806

[ 4 ]

43

NON_RANDOMIZED

SINGLE_GROUP

4SUPPORTIVE_CARE

0NONE

false

0ALL

false

The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® and GW-2000-02.

Subjects who have previously participated in GWCA0101, a two week (two days baseline and two weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® (containing delta-9-tetrahydrocannabinol \[THC\] and cannabidiol \[CBD\]) and GW-2000-02 (containing THC alone) in subjects with cancer-related pain are screened, and if eligible begin dosing with open-label Sativex®. They are allowed to self-titrate their study medication to symptom resolution or maximum tolerated/allowable dose of 130 mg THC and 120 mg CBD and have the opportunity to request a change from Sativex® to GW-2000-02 if they or the investigator consider their response less than optimal. Subjects are reviewed for tolerability and evidence of clinical benefit at 7-10 days after Visit 1 and then every four weeks. Continuation within the study is conditional on satisfactory reports of tolerability, efficacy and dosing regime.

Pain Cancer

Palliative Care Pain Cancer

null

2

arm 1: Active treatment arm 2: Active treatment

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Containing delta-9-tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml; both as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours. intervention 2: Containing THC, 27 mg/ml, as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg) in 24 hours.

intervention 1: Sativex intervention 2: GW-2000-02

1

Shrewsbury | N/A | United Kingdom | -2.75208 | 52.71009

0

NCT00675948

[ 5 ]

22

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

This study will compare the effectiveness of two atypical antipsychotic medications, olanzapine and aripiprazole, in treating people with anorexia nervosa.

Anorexia nervosa (AN) is a disease of disordered eating that is characterized by self-starvation, often leading to extreme weight loss and difficulty maintaining a normal weight. Symptoms and behaviors of AN may include distorted body image, obsessive exercise, lack of menstruation among women, binge and purge eating behaviors, and intense fear of weight gain. Furthermore, people with AN are at a high risk of other mental disorders, such as depression and anxiety, and medical complications, such as organ damage, heart failure, and osteoporosis. Current treatments for AN include nutrition counseling, psychotherapy, and medication. Previous studies have suggested that certain medications usually used to treat schizophrenia, also known as atypical antipsychotic drugs, may be helpful in treating people with AN. Specifically, the atypical antipsychotic medications olanzapine and aripiprazole may be effective in improving overall symptoms of AN and in restoring weight to normal levels. This study will compare the effectiveness of olanzapine and aripiprazole in treating people with AN. Participation in this study will last 12 weeks. All participants will first undergo baseline assessments that will include questionnaires and interviews about AN symptoms, a physical exam, vital sign measurements, an electrocardiograph (EKG), and a blood draw. Participants will then be assigned randomly to 12 weeks of treatment with daily olanzapine or aripiprazole. Participants will meet with a study doctor weekly over the 12 weeks of treatment. During these visits, the study doctor will monitor participants' progress, medication dosage, vital signs, and side effects. In addition, participants will undergo repeat blood draws every 4 weeks and repeat questionnaires every month of the treatment period. Upon completing the 12 weeks of treatment, participants will repeat most baseline assessments.

Eating Disorders

Atypical Antipsychotics Anorexia Nervosa

null

2

arm 1: Participants will take olanzapine arm 2: Participants will take aripiprazole

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Participants will take olanzapine daily for 12 weeks. intervention 2: Participants will take aripiprazole daily for 12 weeks.

intervention 1: Olanzapine intervention 2: Aripiprazole

2

0

NCT00685334

[ 2 ]

30

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

false

This study will determine whether the CT formulation of famotidine taken with and without water is bioequivalent to the FCT formulation. The primary hypothesis is that the area under the concentration-time curve (AUC) and the maximum plasma concentration (Cmax) of a single dose of famotidine 20 mg CT without water are equivalent to a single dose of famotidine 20 mg FCT with water.

null

Heartburn

null

6

arm 1: Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 3). arm 2: Participants received famotidine 20 mg CT as a single dose without water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 3). arm 3: Participants received famotidine 20 mg CT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 3). arm 4: Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 3). arm 5: Participants received famotidine 20 mg CT as a single dose without water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 3). arm 6: Participants received famotidine 20 mg CT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 3).

[ 0, 0, 0, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Famotidine 20 mg oral film-coated tablet taken once daily intervention 2: Famotidine 20 mg oral chewable tablet taken once daily

intervention 1: Famotidine FCT intervention 2: Famotidine CT

0

null

0

NCT00945750

[ 4 ]

19

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This is an open-label study to evaluate the efficacy and safety of Aptalis' (formerly Eurand) pancreatic enzyme product (PEP) microtabs in pediatric participants under age 7 with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).

The study sample will consist of evaluable participants, all of whom will be children younger than 7 years of age. Participants will receive EUR-1008 (APT-1008) Microtabs formulation. The study design involves a 4-day screening period, a 7-day dose stabilization period, and a 7-day treatment period (excluding an end-of-study evaluation). The optimal dose of EUR-1008 (APT-1008) Microtabs, determined during the dose stabilization period, will be used during the treatment period. Participants are instructed to consume a predefined diet.

Cystic Fibrosis Exocrine Pancreatic Insufficiency

Cystic fibrosis Exocrine Pancreatic Insufficiency Zenpep-1009

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: EUR-1008 (APT-1008) Microtabs contained in a capsule will be administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule will be allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).

intervention 1: EUR-1008 (APT-1008)

14

0

NCT00981214

[ 3 ]

174

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

0ALL

null

The primary objective was to evaluate the safety of dabigatran etexilate(BIBR 1048) administered orally at doses of 110 and 150 mg, twice daily, for 12 weeks in patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent) in comparison with warfarin.

null

Atrial Fibrillation

null

3

arm 1: Dabigatran etexilate 110 mg capsule, twice a day, oral administration arm 2: Dabigatran etexilate 150 mg capsule, twice a day, oral administration arm 3: Dose-adjusted warfarin based on target INR values

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Dabigatran etexilate 110 mg capsule, twice a day, oral administration intervention 2: Dabigatran etexilate 150 mg capsule, twice a day, oral administration intervention 3: Dose-adjusted warfarin based on target INR values

intervention 1: Dabigatran etexilate intervention 2: Dabigatran etexilate intervention 3: Warfarin

28

Aki-gun, Hiroshima | N/A | Japan | 132.45 | 34.4 Fukuoka, Fukuoka | N/A | Japan | N/A | N/A Fukuoka, Fukuoka | N/A | Japan | N/A | N/A Himeji, Hyogo | N/A | Japan | N/A | N/A Iizuka,Fukuoka | N/A | Japan | N/A | N/A Kyoto, Kyoto | N/A | Japan | N/A | N/A Nagoya, Aichi | N/A | Japan | N/A | N/A Nagoya, Aichi | N/A | Japan | N/A | N/A Naka-gun, Ibaragi | N/A | Japan | 135.56828 | 34.81641 Okayama, Okayama | N/A | Japan | N/A | N/A Okayama, Okayama | N/A | Japan | N/A | N/A Oota, Tokyo | N/A | Japan | N/A | N/A Osaka, Osaka | N/A | Japan | N/A | N/A Osaka, Osaka | N/A | Japan | N/A | N/A Osaka, Osaka | N/A | Japan | N/A | N/A Osaka, Osaka | N/A | Japan | N/A | N/A Sakai, Osaka | N/A | Japan | N/A | N/A Sapporo, Hokkaido | N/A | Japan | 141.35 | 43.06667 Sapporo, Hokkaido | N/A | Japan | 141.35 | 43.06667 Sendai, Miyagi | N/A | Japan | N/A | N/A Shinjuku, Tokyo | N/A | Japan | N/A | N/A Suita, Osaka | N/A | Japan | N/A | N/A Suita, Osaka | N/A | Japan | N/A | N/A Tokorozawa, Saitama | N/A | Japan | N/A | N/A Toyama, Toyama | N/A | Japan | N/A | N/A Tsuchiura, Ibaragi | N/A | Japan | N/A | N/A Ueda, Nagano | N/A | Japan | N/A | N/A Yokohama, Kanagawa | N/A | Japan | N/A | N/A

0

NCT01136408

[ 2 ]

15

NA

SINGLE_GROUP

0TREATMENT

0NONE

true

0ALL

false

This was a phase 1, open label, multiple dose study in healthy male and female volunteers. Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours. The objective of this study in healthy volunteers was to determine the safety, tolerability, and pharmacokinetics of multiple doses of intranasal ketorolac tromethamine.

null

Healthy Volunteers

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.

intervention 1: Ketorolac tromethamine

1

Manchester | N/A | United Kingdom | -2.23743 | 53.48095

0

NCT01363050

[ 4 ]

115

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg rocuronium after reversal at 3 minutes by 16.0 mg/kg of sugammadex compared with recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.

null

Anesthesia, General

null

2

arm 1: Participants were to receive a single bolus dose of 1.2 mg/kg rocuronium. Three minutes after the start of the rocuronium administration, they were to receive a single bolus dose of 16.0 mg/kg sugammadex. arm 2: Participants were to receive a single bolus dose of 1.0 mg/kg succinylcholine and allowed to recovery spontaneously from neuromuscular blockade.

[ 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Single bolus intravenous (IV) dose of 16.0 mg/kg sugammadex intervention 2: Single bolus IV dose of 1.0 mg/kg succinylcholine intervention 3: Single bolus IV dose of 1.2 mg/kg rocuronium

intervention 1: Sugammadex intervention 2: Succinylcholine intervention 3: Rocuronium

0

null

0

NCT00474253

[ 4 ]

86

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg/kg or 4.0 mg/kg sugammadex (Org 25969, MK-8616) given as a reversal agent for 0.6 mg/kg (0.15 mg/kg maintenance dose) rocuronium (Zemuron®) in participants diagnosed with or having a history of pulmonary disease. All drug administration will be via the intravenous (IV) route.

null

Anesthesia, General

null

2

arm 1: After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 2.0 mg/kg. arm 2: After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 4.0 mg/kg.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Sugammadex solution for injection. intervention 2: Rocuronium bromide solution for injection.

intervention 1: Sugammadex intervention 2: Rocuronium

0

null

0

NCT00475215

[ 4 ]

135

RANDOMIZED

PARALLEL

0TREATMENT

null

false

0ALL

null

This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for RLS.

null

Restless Legs Syndrome Restless Legs Syndrome (RLS)

RLS Ropinirole Restless Legs Syndrome

null

6

arm 1: Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg controlled release for Restless Legs Syndrome (CR-RLS) in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4. arm 2: Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4. arm 3: Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4. arm 4: Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4. arm 5: Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4. arm 6: Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.

[ 0, 0, 0, 0, 0, 0 ]

8

[ 0, 0, 0, 0, 0, 0, 0, 0 ]

intervention 1: Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 1.0mg of active drug substance. intervention 2: Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2.0mg of active drug substance. intervention 3: Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 1 mg. intervention 4: Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg. intervention 5: Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2mg of the active drug substance. intervention 6: Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 3mg of the active drug substance. intervention 7: Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg. intervention 8: Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 3 mg.

intervention 1: Ropinirole IR 1 mg intervention 2: Ropinirole IR 2 mg intervention 3: Ropinirole IR 1 mg Placebo intervention 4: Ropinirole IR 2 mg Placebo intervention 5: Ropinirole CR 2 mg intervention 6: Ropinirole CR 3 mg intervention 7: Ropinirole CR 2 mg Placebo intervention 8: Ropinirole CR 3 mg Placebo

30

0

NCT00256854

[ 5 ]

48

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will evaluate the safety and tolerability of PEGASYS plus ribavirin in previous intravenous (iv) drug users who have CHC and are currently enrolled in a methadone maintenance treatment program. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.

null

Hepatitis C, Chronic

null

2

arm 1: Participants will receive the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1. arm 2: Participants will receive the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 180 micrograms sc weekly for 24 weeks (G 2/3) or 48 weeks (G 1) intervention 2: 1000/1200mg (\< or \>= 75 kg, respectively), po in two doses daily for 48 weeks (G 1) or 800 mg po in two doses daily for 24 weeks (G 2/3)

intervention 1: peginterferon alfa-2a [Pegasys] intervention 2: ribavirin

7

1

NCT00087594

[ 3 ]

255

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

4QUADRUPLE

false

1FEMALE

null

This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.

null

Breast Cancer Metastases Bone Metastases in Subjects With Advanced Breast Cancer

Breast Cancer Cancer

null

6

arm 1: Denosumab 60 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks. arm 2: Denosumab 120 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks. arm 3: Denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks. arm 4: Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion for 25 weeks. arm 5: Denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks. arm 6: Denosumab 30 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.

[ 0, 0, 0, 1, 0, 0 ]

2

[ 2, 0 ]

intervention 1: Denosumab administered by subcutaneous injection intervention 2: Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid

intervention 1: Denosumab intervention 2: IV Bisphosphonates

0

null

0

NCT00091832

[ 4 ]

39

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to evaluate the long-term efficacy and safety of rhASB treatment in patients with Mucopolysaccharidosis VI.

null

Mucopolysaccharidosis VI

null

2

arm 1: N-acetylgalactosamine 4-sulfatase arm 2: None

[ 5, 5 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: N-acetylgalactosamine 4-sulfatase intervention 2: Placebo/rhASB

1

Novato | California | United States | -122.5697 | 38.10742

0

NCT00104234

[ 3 ]

1

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of the study is to determine whether pemetrexed and gemcitabine cause good tumour shrinkage when given to patients with previously untreated extensive-stage small cell lung cancer. The second purpose is to see if the side effects appear better than what is expected with standard chemotherapy.

Extensive-stage small cell lung carcinoma is incurable. Present therapies are toxic and responses are short lived. This phase II, single arm, window of opportunity study will assess the response rate and toxicity of pemetrexed and gemcitabine in this cohort.

Carcinoma, Small Cell

Lung cancer Phase II Drug Therapy

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: pemetrexed and gemcitabine

3

0

NCT00129974

[ 3 ]

68

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in subjects 2 to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at approximately 10 investigational sites in the U.S. for up to 15 weeks. Subjects will be randomly assigned to either a low dose or a high dose. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, subjects will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.

LGS poses a significant treatment challenge. While antiepileptic medications are the mainstay of treatment, no one antiepileptic drug (AED) provides satisfactory relief for all or most patients with LGS and a combination of treatments is often required. Many patients with LGS are refractory to standard AED treatment. More effective and better tolerated treatment options are needed for this population of medically intractable epilepsy patients. Clobazam is unique in that it is the only non-1, 4-benzodiazepine used in the treatment of epilepsy.

Epilepsy Epilepsy, Generalized Seizures

null

2

arm 1: None arm 2: None

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 5 to 10 mg/day with doses in the morning and at bedtime; orally intervention 2: 5 to 40 mg/day with doses in the morning and at bedtime; orally

intervention 1: Clobazam Low Dose intervention 2: Clobazam High Dose

14

0

NCT00162981

[ 3 ]

14

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Patients who have been treated for hepatitis C virus (HCV) infection who have failed to respond to anti-viral treatment are often concerned about their ongoing liver disease and are therefore looking for alternative treatments which might prevent fibrosis progression. This view is endorsed by patient representative groups (including Charles Gore at the HepC Trust) who have welcomed this trial protocol. The study is a single centred, prospective, open labelled design. Practical as well as safety concerns dictated that the study could not be conducted in a blinded fashion, since patients taking anticoagulation require monitoring. The study consisted of two 8 week phases: Phase 1 and Phase 2. Phase 1 (observation phase, 0 to 8 weeks) and Phase 2 (treatment phase with warfarin anticoagulation, 8 to 16 weeks). Study completed at end of Phase 2.

Background: Convincing evidence exists outlining a role for the coagulation system in the pathogenesis of liver fibrosis. In vivo and in vitro studies have suggested a role for thrombin and FXa in activating hepatic stellate cells and epidemiological studies have demonstrated that prothrombotic states accelerate liver fibrosis (Wright et al., 2003). Hence if prothrombotic states accelerate liver fibrosis, conversely anticoagulation should slow liver fibrosis. Animal studies have confirmed this (Anstee et al., 2008; Duplantier et al., 2004), and confirmed the beneficial effect of inhibiting the coagulation cascade. The number of patients with HCV infection on anticoagulants is small and there is no published case series. Similarly there are problems assessing disease progression using patients with haemophilia and HCV infection. The therapeutic use of anticoagulation to prevent fibrosis in humans is not without precedent, and warfarin has demonstrated a survival benefit in pulmonary fibrosis (Kubo et al., 2005). The antifibrotic potential of warfarin anticoagulation needs to be formally assessed in the setting of a clinical trial using patients with documented liver fibrosis. Most previous human studies of antifibrotics have taken place in patients with chronic HCV infection who have failed anti-viral therapy, as they are a model of progressive fibrosis (Anstee et al., 2009). Study aims: 1. To evaluate if any potential effect on the progression of liver fibrosis in patients infected with Hepatitis C virus, with moderate severity liver fibrosis is demonstrable with anticoagulation. 2. To evaluate the safety of anticoagulation in patients infected with Hepatitis C virus infection, with moderate severity liver fibrosis. Patients: The study was approved by the St. Mary's Hospital Ethics committee and conducted in accordance with the principles of the Declaration of Helsinki. Potential participants were identified via the departmental Hepatitis C database. All potential candidates were screened for the inclusion and exclusion criteria. Inclusion criteria: Patients were eligible for inclusion if they were aged greater than 17 years of age, had evidence of active Hepatitis C viral replication (HCV RNA PCR positive), ALT of greater than 40 iu/ml, a modified histology activity index fibrosis score (Ishak et al., 1995) of greater than 2 but less than 5 on liver biopsy within the last five years, and had failed antiviral therapy for Hepatitis C in the last 5 years. Exclusion criteria: Patients requiring anticoagulation for existing clinical indications; standard contraindications to anticoagulation (active peptic ulcer disease, past history of haemorrhagic stroke, thrombocytopaenia, platelets count \< 100 x109 /L); clinical evidence of portal hypertension; known cerebrovascular abnormalities; HIV antibody positive; alcohol abuse (\> 40 units/week); menhorragia and pregnancy. Potential qualifying subjects were initially contacted by telephone to be informed about the study and arrange a formal screening visit. During the screening visit, entry criteria were confirmed and all patients who agreed to participate were required to give written informed consent. Study design: The study employed a single centred, prospective, open labelled design. Practical as well as safety concerns dictated that the study could not be conducted in a blinded fashion, since patients taking anticoagulation require monitoring. The study consisted of two 8 week phases: Phase 1 and Phase 2. Phase 1 (Week 0 to Week 8) Phase 1 of the study consisted of 8 weeks of observation, which commenced following a baseline visit at week 0. At the baseline study routine blood tests and non-invasive markers of fibrosis were performed. No placebo was given during the observation period. At week 8 patients underwent their second study visit during which routine blood tests and evaluation with non-invasive markers of fibrosis were repeated. The week 8 study visit marked the completion of Phase 1, following which patients entered Phase 2 of the study. Phase 2 (Week 8 to Week 16) Phase 2 of the study consisted of 8 weeks of anticoagulation with warfarin. In previous animal studies (Anstee et al., 2008), warfarin anticoagulation to achieve a whole blood clotting of twice the normal range was sufficient to retard fibrosis significantly, hence the international normalised ration (INR) was aimed to be maintained between 2 to 3 during the treatment period. Patients were given a standard induction regimen of warfarin in keeping with the outpatient warfarin loading protocol of the hospital's anticoagulation clinic. Warfarin was supplied by the hospital pharmacy. Routine INR monitoring and warfarin dosing was undertaken by the anticoagulation clinic on a weekly basis. Patients were monitored at these visits for any adverse events related to the treatment. At week 16, following 8 weeks of anticoagulation, a further study visit was organised. Routine bloods tests and non-invasive markers of fibrosis were performed at this visit, which marked the completion of each patient's participation in the study.

Liver Fibrosis

Hepatic fibrosis anticoagulation Coumarin Warfarin Chronic hepatitis C virus infection

null

1

arm 1: Anticoagulated with warfarin to maintain an INR of 2-3 between 8 and 16 weeks (treatment period).

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Warfarin

1

London | N/A | United Kingdom | -0.12574 | 51.50853

0

NCT00180674

[ 5 ]

401

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This study is randomized, Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) controlled study on acute ischemic stroke. The primary endpoints were the rate of patients with modified Rankin Scale score of 0-1 at 3 months.

null

Cerebral Infarction

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening. intervention 2: Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.

intervention 1: Edaravone intervention 2: Sodium Ozagrel

0

null

0

NCT00200356

[ 4 ]

346

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.

null

Migraine

null

2

arm 1: Rizatriptan (MK0462)10 mg orally disintegrating tablet/oral lyophilisate arm 2: matching placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack. intervention 2: One dose matching placebo to Rizatriptan to treat one migraine attack.

intervention 1: Comparator: Rizatriptan intervention 2: Comparator: Placebo

0

null

0

NCT00250458

[ 3 ]

131

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants with active Crohn's Disease.

This is a multicenter, randomized study of IL-12p40 (CNTO 1275), hereafter referred to as ustekinumab, in 2 populations of participants with moderately to severely active Crohn's disease of at least 6 weeks duration. A total of approximately 120 volunteers will participate in this study in Canada, Belgium, and the United States. Two separate groups of participants (Population 1 and Population 2) will be evaluated. The primary population of participants (Population 1) will consist of approximately 100 participants with Crohn's disease despite treatment with standard Crohn's disease medications (includes agents to decrease intestinal inflammation such as 5-ASA medications such as PENTASA, ASACOL), corticosteroids such as prednisone and/or other drugs known to suppress the immune system called immunomodulators such as azathioprine, 6-mercaptopurine, methotrexate, infliximab or adalimumab \[marketed under the trade name of HUMMIRA\]). Participants in Population 1 will be randomly assigned (assigned by chance, like "flipping a coin") to double-blind treatment (participants and study staff will not know the identity of the treatments) with ustekinumab and placebo (inactive substance) in 1 of 4 treatment groups as follows: (1) 4 weeks of treatment with ustekinumab 90 mg followed by 4 weeks of treatment with placebo injected subcutaneously (SC, under the skin), (II) 4 weeks of placebo followed by 4 weeks of ustekinumab 90 mg injected SC, (III) 1 intravenous (IV, in the vein) infusion of ustekinumab 4.5 mg/kg followed by 1 IV infusion of placebo, and (IV) 1 IV infusion of placebo followed by 1 IV infusion of ustekinumab 4.5 mg/kg. Population 2 consists of approximately 20 participants who failed to respond to previous therapy with infliximab (trade name REMICADE), a type of antibody that decreases inflammation in patients with moderate to severe Crohn's disease). All participants in Population 2 will receive open-label (un-blinded) treatment with ustekinumab 4.5 mg/kg administered SC for 4 weeks or as one IV infusion. Placebo will not be given to participants in Population 2. The duration of the study for each participant is 28 weeks (not including a screening period of up to 2 weeks) with participants returning at Week 54 to have blood samples collected to assess the concentration of ustekinumab and antibodies to ustekinumab. Adverse events (side-effects) as a measure of safety and tolerability and results from routine laboratory tests will be monitored and reported throughout the study from the time that informed consent is documented up to 3 days after the final blood sample collection at Week 54. Note: doses of ustekinumab used in the study were adjusted by a factor of 0.9 to be consistent with the corrected absorptivity constant for ustekinumab. Therefore, ustekinumab doses of 100 mg and 5 mg/kg previously stated in the study protocol have been restated as 90 mg and 4.5 mg/kg, respectively. No change was made to the amount of ustekinumab given to participants in this study.

Crohn Disease

Crohn Disease Biologic Infusion Injection CNTO 1275 Ustekinumab C01275 IL-12p40

null

6

arm 1: Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2. arm 2: Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2. arm 3: Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2. arm 4: Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2. arm 5: Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2. arm 6: Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.

[ 0, 0, 0, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: one 90 mg SC injection each week for 4 weeks (Weeks 0-3 during Intervention Period 1 or Weeks 8-11 during Intervention Period 2 for Population 1 or Weeks 0-3 during Intervention Period 1 for Population 2) intervention 2: one IV infusion of 4.5 mg/kg over a period of not less than 2 hours at Week 0 in Intervention Period 1 or Week 8 in Intervention Period 2 for Population 1 or at Week 0 in Intervention Period 1 for Population 2 intervention 3: one SC injection each week for 4 weeks (Weeks 0-3 in Intervention Period 1 or Weeks 8-11 in Intervention Period 2 for Population 1 or at Weeks 0-3 in Intervention Period 1 for Population 2) intervention 4: one IV infusion over a period of not less than 2 hours at Week 0 in Intervention Period 1 for Population 1 and Population 2 or at Week 8 in Intervention Period 2 for Population 1

intervention 1: Ustekinumab 90 mg intervention 2: Ustekinumab 4.5 mg/kg intervention 3: Placebo SC intervention 4: Placebo IV

57

0

NCT00265122

[ 2 ]

24

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

This study evaluates the safety of infliximab in infants and children with acute Kawasaki Disease.

This study is an exploratory, pilot study to examine tolerance and pharmacokinetics of infliximab in infants and children with acute Kawasaki Disease.

Kawasaki Disease

null

2

arm 1: Subjects who did not respond to the first dose of IVIG received a 2nd dose of IVIG in this arm (2g/kg) arm 2: Remicade (5mg/kg) single dose

[ 1, 0 ]

2

[ 0, 2 ]

intervention 1: Remicade was 5 mg/kg IV (single dose) intervention 2: 2nd dose of IVIG (2g/kg)

intervention 1: Infliximab (Remicade) intervention 2: Intravenous immunoglobulin (IVIG)

1

San Diego | California | United States | -117.16472 | 32.71571

0

NCT00271570

[ 2 ]

130

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this trial is to assess whether rotigotine has an effect on the electrical activity of the heart. Moxifloxacin infusion is used as positive control to assess assay sensitivity.

null

Parkinson's Disease

advanced-stage idiopathic Parkinson's disease

null

2

arm 1: Rotigotine Patch arm 2: Placebo patch

[ 0, 2 ]

5

[ 0, 10, 0, 10, 10 ]

intervention 1: Rotigotine patch applied once daily for a 24-hour period. Rotigotine dose schedule (patch application days): Day 1 through Day 7: 9.0 mg/day; Day 8 through Day 14: 18.0 mg/day; Day 15 through Day 21: 27.0 mg/day; Day 22 through Day 28: 36.0 mg/day; Day 29 through Day 35: 45.0 mg/day; Day 36 through Day 42: 54.0 mg/day; Day 43 through Day 44: 45.0 mg/day; Day 45 through Day 46: 36.0 mg/day; Day 47 through Day 48: 27.0 mg/day; Day 49 through Day 50: 18.0 mg/day; Day 51 through Day 52: 9.0 mg/day; intervention 2: Placebo patch applied once daily for a 24-hour period. Size and number of patches matching to rotigotine dose schedule (patch application days): Day 1 through Day 7: 9.0 mg/day; Day 8 through Day 14: 18.0 mg/day; Day 15 through Day 21: 27.0 mg/day; Day 22 through Day 28: 36.0 mg/day; Day 29 through Day 35: 45.0 mg/day; Day 36 through Day 42: 54.0 mg/day; Day 43 through Day 44: 45.0 mg/day; Day 45 through Day 46: 36.0 mg/day; Day 47 through Day 48: 27.0 mg/day; Day 49 through Day 50: 18.0 mg/day; Day 51 through Day 52: 9.0 mg/day; intervention 3: Moxifloxacin 400 mg/250 mL iv solution infused over 1h once either on Day 32 or on Day 39 intervention 4: Placebo saline solution 250 mL infused over 1h once either on Day 32 or on Day 39 intervention 5: Placebo saline solution 250 mL infused over 1h once on both Day 32 and on Day 39

intervention 1: Rotigotine intervention 2: Placebo intervention 3: Moxifloxacin infusion intervention 4: Placebo infusion intervention 5: Placebo infusion

2

Bloemfontein | N/A | South Africa | 26.214 | -29.12107 George | N/A | South Africa | 22.46173 | -33.963

0

NCT00292227

[ 5 ]

418

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.

null

Rhinitis, Allergic, Seasonal

Levocetirizine Xyzal Rhinitis Allergic Seasonal Ragweed

null

3

arm 1: Placebo was administered orally on Days 1 and 2. arm 2: 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. arm 3: 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.

[ 2, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: * Pharmaceutical form: Over-encapsulated tablet * Route of administration: Oral use intervention 2: * Pharmaceutical form: Over-encapsulated tablet * Concentration: 10 mg * Route of administration: Oral use intervention 3: * Pharmaceutical form: Over-encapsulated tablet * Concentration: 5 mg * Route of administration: Oral use

intervention 1: Placebo intervention 2: Montelukast intervention 3: Levocetirizine

1

Kingston | Ontario | Canada | -76.48098 | 44.22976

0

NCT00295022

[ 3 ]

296

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

To evaluate the safety and efficacy of 8 weeks of treatment with MN-001 at 500 mg bid, 500 mg once daily vs. placebo in patients with Interstitial Cystitis.

This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of two dosing regimens of MN-001 in patients with Interstitial Cystitis (IC). Patients will be screened for study eligibility within seven to nine days of randomization. Eligible patients will be randomized in a 1:1:1 ratio to receive either 500 mg MN-001 bid, 500 mg MN-001 once daily or placebo. Patients will be dispensed study drug beginning at Baseline (Visit 2) and will return to the study center for Visit 3 (28 days ± 2 days after Baseline), and Visit 4 (56 days ± 2 days after Baseline), at end of study for safety and efficacy assessments. The patient will be contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up. Study drug will be dispensed at Visits 2 and 3. Safety assessments will include adverse events, physical examinations, clinical laboratory testing, and changes in vital signs. Efficacy assessments include percentage of patients at least "moderately improved" for each treatment group using the patient reported Global Response Assessment (GRA) (see Appendix 1). Secondary assessments include a decrease in bladder pain/urgency based on change in the patient rating from baseline to endpoint using the GRA (see Appendix 1), modified Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale (see Appendix 2) and the O'Leary Sant IC Symptom and Problem Index.

Interstitial Cystitis

Interstitial Cystitis urgency frequency MN-001 Global Response Assessment bladder pain/urgency O'Leary Sant IC Symptom and Problem Index

null

2

arm 1: None arm 2: placebo tablets

[ 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Eligible patients received 500 mg MN-001 bid intervention 2: Eligible patients received 500 mg MN-001 once daily (qd) intervention 3: Eligible patients received placebo

intervention 1: MN-001 BID intervention 2: MN-001 intervention 3: Placebo

28

0

NCT00295854

[ 4 ]

857

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.

null

Hypercholesterolemia Dyslipidemia

hypercholesterolemia kowa dyslipidemia pitavastatin NK-104 Primary Hypercholesterolemia or Combined Dyslipidemia

null

4

arm 1: Pitavastatin 2 mg once daily arm 2: Simvastatin 20 mg once daily arm 3: Pitavastatin 4 mg once daily arm 4: Simvastatn 40 mg once daily

[ 0, 1, 0, 1 ]

2

[ 0, 0 ]

intervention 1: Pitavastatin once daily intervention 2: Simvastatin once daily

intervention 1: Pitavastatin intervention 2: Simvastatin

42

Helsinki | N/A | Finland | 24.93545 | 60.16952 Helsinki | N/A | Finland | 24.93545 | 60.16952 Helsinki | N/A | Finland | 24.93545 | 60.16952 Tampere | N/A | Finland | 23.78712 | 61.49911 Turku | N/A | Finland | 22.26869 | 60.45148 Bologna | N/A | Italy | 11.33875 | 44.49381 Chieti | N/A | Italy | 14.16494 | 42.34827 Ferrara | N/A | Italy | 11.62057 | 44.83804 Genova | N/A | Italy | 11.87211 | 45.21604 Modena | N/A | Italy | 10.92539 | 44.64783 Napoli | N/A | Italy | 14.5195 | 40.87618 Palermo | N/A | Italy | 13.3636 | 38.1166 Parma | N/A | Italy | 10.32618 | 44.79935 Treviglio | N/A | Italy | 9.59102 | 45.52081 Trieste | N/A | Italy | 13.77678 | 45.64953 Fredrikstad | N/A | Norway | 10.9298 | 59.2181 Kongsberg | N/A | Norway | 9.65017 | 59.66858 Oslo | N/A | Norway | 10.74609 | 59.91273 Oslo | N/A | Norway | 10.74609 | 59.91273 Skedsmokorset | N/A | Norway | 11.03278 | 60.00459 Kemerovo | N/A | Russia | 86.08333 | 55.33333 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Novosibirsk | N/A | Russia | 82.94339 | 55.03442 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Bath | N/A | United Kingdom | -2.36172 | 51.3751 Chesterfield | N/A | United Kingdom | -1.41667 | 53.25 Plymouth | N/A | United Kingdom | -4.14305 | 50.37153 Sheffield | N/A | United Kingdom | -1.4659 | 53.38297 Surrey | N/A | United Kingdom | N/A | N/A Wiltshire | N/A | United Kingdom | N/A | N/A Wiltshire | N/A | United Kingdom | N/A | N/A Wiltshire | N/A | United Kingdom | N/A | N/A Wiltshire | N/A | United Kingdom | N/A | N/A Wiltshire | N/A | United Kingdom | N/A | N/A

0

NCT00309777

[ 5 ]

22

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe 10 mg coadministered with atorvastatin 10 mg versus atorvastatin 10 mg in Indonesian population with primary hypercholesterolemia.

null

Hypercholesterolemia Coronary Arteriosclerosis

null

2

arm 1: Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin. arm 2: Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.

[ 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 10 mg ezetimibe, orally, daily for 6 weeks, added to ongoing treatment with 10 mg atorvastatin intervention 2: 10 mg/day matching placebo to ezetimibe, orally, daily for 6 weeks, added to ongoing 10 mg atorvastatin intervention 3: 10 mg/day atorvastatin, orally, (ongoing treatment in participants)

intervention 1: Ezetimibe intervention 2: Placebo intervention 3: Atorvastatin 10 mg

0

null

0

NCT00319449

[ 4 ]

201

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.

null

Pain, Postoperative

Bunionectomy Bunion surgery Post-operative pain

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 25 mg every 6 hours intervention 2: Placebo every 6 hours

intervention 1: diclofenac potassium (XP21L) intervention 2: Placebo

6

0

NCT00366444

[ 2 ]

8

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Phase 1 Open-label treatment with MPC-2130 for subjects with refractory cancer.

MPC-2130 Phase 1 Clinical study was designed to evaluate its safety and pharmacokinetic profile in patients with advanced metastatic tumors or blood cancers as well as refractory cancers that progressed despite previous chemotherapy.

Cancer

Oncology Cancer Blood Cancers

null

0

null

1

[ 0 ]

intervention 1: MPC-2130 10 mg/mL administered by intravenous infusion over 1-2 hours

intervention 1: MPC-2130

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00387153

[ 3 ]

140

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This is a phase II multi-centre study in 140 patients undergoing elective PCI to obtain the information on dose-response of argatroban in pharmacodynamic markers and to assess the anticoagulation, safety and efficacy of argatroban in reference to unfractionated heparin, in combination with dual antiplatelet therapy.

This is a phase II multi-centre study in Europe in patients with stable coronary artery disease or troponin negative unstable angina undergoing elective PCI, to obtain the information on the safety and effects on various pharmacodynamic markers, of three doses of argatroban in combination with clopidogrel and aspirin, and to assess the results of argatroban and unfractionated heparin, both used in combination with clopidogrel and aspirin, on clinical outcomes, adequacy of anticoagulation, various pharmacodynamic markers (approximately 35 patients per group).

Coronary Artery Disease Angina, Unstable

Argatroban Direct thrombin inhibitor Percutaneous coronary intervention Activated clotting time PCI ACT

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None intervention 4: None

intervention 1: Argatroban intervention 2: Argatroban intervention 3: Argatroban intervention 4: Heparin

8

Aalst | N/A | Belgium | 4.0355 | 50.93604 Bad Nauheim | N/A | Germany | 8.73859 | 50.36463 Cologne | N/A | Germany | 6.95 | 50.93333 Dachau | N/A | Germany | 11.43402 | 48.26 Düren | N/A | Germany | 6.49299 | 50.80434 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Halle | N/A | Germany | 11.97947 | 51.48158 Mainz | N/A | Germany | 8.2791 | 49.98419

0

NCT00508924

[ 2 ]

56

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This study is being conducted to determine what dexmedetomidine does to the body and in turn, what how the body handles the medication. This medication, for the purpose of this trial, is used as a short-term sedative for infants who are immediately post-operative from cardiac surgery and have a breathing tube and are breathing with the assistance of a mechanical ventilator or breathing machine.

This is a single center, dose escalation study of a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours in infants who are immediately post-operative from cardiac surgery and require tracheal intubation with mechanical ventilation in the post-operative period. Three bolus doses and infusion doses will be administered to a total of 36 evaluable patients.

Hypoplastic Left Heart Tetralogy of Fallot Tricuspid Atresia

Postoperative from cardiac surgery Dexmedetomidine

null

1

arm 1: A predetermined dose of Dexmedetomidine

[ 0 ]

1

[ 0 ]

intervention 1: Dosage levels: Dose Level 1: Loading dose 0.35mcg/kg and CIVI 0.25mcg/kg/hr Dose Level 2: Loading Dose of 0.7mcg/kg and CIVI 0.5mcg/kg/hr and Dose Level 3: Loading Dose 1 mcg/kg and CIVI 0.75 mcg/kg/hr.

intervention 1: Dexmedetomidine

0

null

0

NCT00573066

[ 4 ]

246

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving peripheral neuropathic pain associated with allodynia.

This was a 15 week (one week baseline and fourteen weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® in subjects with PNP, associated with allodynia. Subjects were screened to determine eligibility and completed a seven-day baseline period. Subjects then returned to the centre for assessment, randomisation and dose introduction. Visits occurred at the end of weeks two, six, ten and at the end of the study (treatment week 14) or earlier if they withdrew. A follow up visit occurred 28 days after completion or withdrawal. Subjects in this study were given the opportunity to be enrolled in an open label extension study.

Pain Peripheral Neuropathy

Pain Peripheral Neuropathy Allodynia

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours intervention 2: containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.

intervention 1: Sativex intervention 2: Placebo

1

Glasgow | West Lothain | United Kingdom | -4.25763 | 55.86515

0

NCT00710554

[ 3 ]

32

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

null

The primary objective of this study is to assess the efficacy (bronchoprotection) and safety of single doses of BI 1744 CL inhalation solution (2, 5, 10 and 20 mcg) delivered via the Respimat® inhaler, in patients with intermittent asthma.

null

Asthma

null

5

arm 1: Single dosing of low dose Olodaterol inhaled orally from Respimat Device arm 2: Single dosing of medium low dose Olodaterol inhaled orally from Respimat Device arm 3: Single dosing of medium high dose Olodaterol inhaled orally from Respimat Device arm 4: Single dosing of high dose Olodaterol inhaled orally from Respimat Device arm 5: Single dosing of Olodaterol placebo inhaled orally from Respimat Device

[ 0, 0, 0, 0, 2 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Placebo device for comparison intervention 2: Olodaterol comparison of low, medium low, medium high and high doses intervention 3: Olodaterol comparison of low, medium low, medium high and high doses intervention 4: Olodaterol comparison of low, medium low, medium high and high doses intervention 5: Olodaterol comparison of low, medium low, medium high and high doses

intervention 1: Placebo intervention 2: Olodaterol (BI1744CL) intervention 3: Olodaterol (BI1744CL) intervention 4: Olodaterol (BI1744CL) intervention 5: Olodaterol (BI1744CL)

4

0

NCT00928668

[ 4 ]

61

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study will evaluate the efficacy and tolerability of subcutaneous (SC) or intramuscular (IM) recombinant human erythropoietin beta (r-HuEPO) in participants with anemia and histologically or cytologically confirmed cancer.

null

Anemia

null

1

arm 1: Anemic cancer participants will receive r-HuEPO for 4 weeks.

[ 0 ]

1

[ 0 ]

intervention 1: All participants will receive r-HuEPO for 4 weeks, at a dose of 10000 international units per day (IU/day) according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.

intervention 1: r-HuEPO

7

Bari | N/A | Italy | 16.86982 | 41.12066 Benevento | N/A | Italy | 14.77816 | 41.1307 Cagliari | N/A | Italy | 9.11917 | 39.23054 Campobasso | N/A | Italy | 14.66737 | 41.55947 Napoli | N/A | Italy | 14.5195 | 40.87618 Palermo | N/A | Italy | 13.3636 | 38.1166 Palermo | N/A | Italy | 13.3636 | 38.1166

0

NCT02767765