ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03781375
Conditions: Juvenile Rheumatoid Arthritis
Sponsor: Amgen
Start date: 2000-08-24; Completion date: 2002-06-24
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to determine the efficacy of etanercept plus methotrexate vs methotrexate alone in pediatric patients with active polyarticular course juvenile rheumatoid arthritis (JRA).

Detailed description:

Arms: arm 1: Participants received placebo subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months. arm 2: Participants received 0.4 mg/kg etanercept subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.
Interventions: intervention 1: Etanercept intervention 2: Placebo to Etanerceot intervention 3: Methotrexate
Intervention descriptions: intervention 1: Administered by subcutaneous injection twice a week intervention 2: Administered by subcutaneous injection twice a week intervention 3: Administered orally or subcutaneously once a week at the same dose as prior to study entry

Protocol documents:
Clinical trial NCT01610700
Conditions: Multiple Sclerosis
Sponsor: Jazz Pharmaceuticals
Start date: 2001-05-01; Completion date: 2002-07-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to compare the efficacy of GW-1000-02 \[named Sativex® in Canada and also named Sativex® Oromucosal Spray\] with placebo in relieving five key symptoms of Multiple Sclerosis after six weeks of therapy.

Detailed description:
Eligible subjects entered a one to two week baseline period; followed by a six week double blind, randomised, parallel group comparison of GW-1000-02 with placebo, self-titrated to symptom resolution or maximum tolerated dose. Existing medication continued at a constant dose.

Primary efficacy comparisons were made between symptom scores recorded during baseline and scores recorded at the end of the parallel group period.

Arms: arm 1: Active treatment arm 2: Control
Interventions: intervention 1: GW-1000-02 intervention 2: Placebo
Intervention descriptions: intervention 1: Containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. The maximum permitted dose of study medication was eight actuations (22 mg THC and 20 mg CBD) in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period. intervention 2: Each actuation of placebo delivered the excipients only.

Protocol documents:
Clinical trial NCT01610713
Conditions: Multiple Sclerosis
Sponsor: Jazz Pharmaceuticals
Start date: 2001-05-01; Completion date: 2002-07-01
Enrollment: 154 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
An open-label extension study in which patients with multiple sclerosis received GW-1000-02 \[named Sativex® in Canada and also named Sativex® Oromucosal Spray\] for four weeks in an open-label manner.

Detailed description:
Subjects who took part in GWMS0001 Part A were invited to continue to receive GW-1000-02 in this four-week open-label part of the study. Subjects received open-label cannabinoid extract (GW-1000-02) for four weeks, either with or without peppermint flavouring, according to their study centre. Subjects who completed the study could choose to continue receiving GW-1000-02 by entering the long-term safety extension follow-on study.

Arms: arm 1: Active treatment.
Interventions: intervention 1: GW-1000-02
Intervention descriptions: intervention 1: Containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. The maximum permitted dose of study medication was eight actuations (22 mg THC and 20 mg CBD) in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.

Protocol documents:
Clinical trial NCT02287415
Conditions: Epilepsy
Sponsor: Bial - Portela C S.A.
Start date: 2002-05-01; Completion date: 2002-07-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Multiple-dose, open-label, single-period study consisting of three consecutive phases

Detailed description:
Multiple-dose, open-label, single-period study consisting of three consecutive phases: Phase A - run-in warfarin dose-finding phase Phase B - warfarin pharmacokinetics (PK) and international normalised ratio (INR) profiling Phase C - warfarin alone at their individualised doses

Arms: arm 1: Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin
Interventions: intervention 1: BIA 2-093 intervention 2: Warfarin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02172742
Conditions: Epilepsy
Keywords: Eslicarbazepine acetate BIA 2-093
Sponsor: Bial - Portela C S.A.
Start date: 2002-05-01; Completion date: 2002-07-25
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate the effects of multiple-dose administration of BIA 2-093 on the steady-state pharmacokinetics of digoxin in healthy subjects.

Detailed description:
Single centre, multiple-dose, double-blind, randomised, placebo-controlled, two-way crossover study in 12 healthy volunteers. The study consisted of two 8-day treatment periods separated by a washout of 10 or more days. During each of the treatment periods the volunteers received either a daily oral dose of BIA 2-093 1200 mg once-daily (od) or matching placebo, concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).

Arms: arm 1: BIA 2-093 1200 mg (2 tablets 600 mg) ESL, Eslicarbazepine acetate

Concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day). arm 2: Placebo (2 tablets matching BIA 2-093 600 mg tablets) PLC, Placebo

Concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).
Interventions: intervention 1: BIA 2-093 intervention 2: Placebo intervention 3: Digoxin
Intervention descriptions: intervention 1: BIA 2-093 1200 mg once-daily intervention 2: matching placebo intervention 3: Digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).

Protocol documents:
Clinical trial NCT00048165
Conditions: Heart Transplantation
Sponsor: Hoffmann-La Roche
Start date: 1999-08-01; Completion date: 2002-08-01
Enrollment: 434 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the number of randomized participants in each treatment group who experience an acute rejection episode in the first 6 months after undergoing cardiac transplantation.

Detailed description:

Arms: arm 1: Daclizumab will be administered as a intravenous dose of 1 milligrams per kilogram \[mg/kg\] on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily \[BID\], cyclosporine 1-4 mg/kg IV or 2-6 mg/kg, and 500-1000 mg IV methylprednisolone peri operative switch to oral at 0.5-1 mg/kg/day followed by tapering. arm 2: Matching placebo will be administered on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily \[BID\], cyclosporine 1-4 mg/kg IV or 2-6 mg/kg orally, and 500-1000 mg IV methylprednisolone peri-op switch to oral at 0.5-1 mg/kg/day followed by tapering.
Interventions: intervention 1: Daclizumab intervention 2: Methylprednisolone intervention 3: Mycophenolate mofetil intervention 4: Placebo intervention 5: cyclosporine
Intervention descriptions: intervention 1: Daclizumab will be administered as 1 mg/kg IV within 12 hours post-op (Day 1), and Days 8, 22, 36 and 50. intervention 2: Methylprednisolone will be administered as 500-1000 mg IV and peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering till 0.0-0.15 mg/kg/day (up to 365 days). intervention 3: Mycophenolate mofetil will be administered as 1.5 grams bid begun post-op, either IV or orally as required up to 365 days. intervention 4: Matching placebo will be administered on Days 1, 8, 22, 36, and 50. intervention 5: Cyclosporine will be administered as 1-4 mg/kg IV or 2-6 mg/kg orally up to 365 days.

Protocol documents:
Clinical trial NCT01604265
Conditions: Multiple Sclerosis Neuropathic Pain
Sponsor: Jazz Pharmaceuticals
Start date: 2002-03-01; Completion date: 2002-08-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the ability of Sativex to relieve central neuropathic pain in multiple sclerosis subjects.

Detailed description:
Multiple sclerosis subjects with a clinical diagnosis of central neuropathic pain entered a seven to ten day baseline period, followed by a four week double blind, randomised, parallel group comparison of Sativex, with placebo. The study medication was self-titrated to symptom resolution or maximum tolerated or allowed dose. Visits occurred at the end of weeks one and four (end of the study) or earlier if they withdrew. A follow-up visit occurred 30 - 40 days after completion or withdrawal.

Arms: arm 1: Placebo control. arm 2: Active treatment.
Interventions: intervention 1: Placebo intervention 2: Sativex
Intervention descriptions: intervention 1: Contained 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. Each actuation delivered 100 μl. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period. intervention 2: Contained delta-9-tetrahydrocannabinol (THC), (25 mg/ml):cannabidiol (CBD), (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg and CBD 2.5 mg). The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.

Protocol documents:
Clinical trial NCT01606176
Conditions: Pain Multiple Sclerosis
Sponsor: Jazz Pharmaceuticals
Start date: 2002-03-01; Completion date: 2002-08-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the ability of a cannabis based medicine extract to relieve chronic refractory pain of neurological origin.

Detailed description:
Patients with Multiple Sclerosis or other defect of neurological function with a qualifying symptom of chronic refractory pain, entered a seven day baseline period, followed by a 21 day randomised, double blind, parallel group comparison of GW-1000-02 with placebo, self-titrated to symptom resolution or maximum tolerated dose. The ability of the cannabis based medicine extract to relieve chronic refractory pain was assessed by the change from baseline in pain score using Box Scale-11 (BS-11) scores recorded in the patients' daily diary.

Arms: arm 1: Each 100 μl actuation contains 2.5 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). The maximum permitted dose was 48 actuations in any 24 hour period (120 mg THC/120 mg CBD). arm 2: Each 100 μl actuation contains the excipients only. The maximum permitted dose was 48 actuations in any 24 hour period
Interventions: intervention 1: GW-1000-02 intervention 2: Placebo
Intervention descriptions: intervention 1: Each actuation of GW-1000-02 (100 μl) delivered a dose containing 2.5 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). The maximum permitted dose of study medication was eight actuations in any three hour period (20 mg THC/20 mg CBD) and 48 actuations in any 24 hour period (120 mg THC/120 mg CBD). intervention 2: Each actuation of placebo (100 μl) delivered the excipients only. The maximum permitted dose of study medication was eight actuations in any three hour period and 48 actuations in any 24 hour period.

Protocol documents:
Clinical trial NCT01606189
Conditions: Pain
Sponsor: Jazz Pharmaceuticals
Start date: 2001-12-01; Completion date: 2002-09-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A study to compare the efficacy of two sublingual cannabinoid based medicine extracts with placebo in the treatment of chronic pain due to brachial plexus injury.

Detailed description:
This study used a three way crossover study design. Eligible patients recorded their symptoms during a one to two week baseline period, then entered a three period, double blind, randomised crossover of GW-1000-02, GW-2000-02 and placebo. Each period lasted two weeks, with no washout between periods. There were six possible treatment sequences. The primary analysis was based on Box Scale-11 pain severity scores recorded throughout the study in patient daily diary booklets. Blood samples were taken from patient-volunteers at the beginning of each period, for measurement of plasma cannabinoid concentration.

Arms: arm 1: Active treatment. arm 2: Active treatment. arm 3: Placebo control.
Interventions: intervention 1: GW-1000-02 intervention 2: GW-2000-02 intervention 3: Placebo
Intervention descriptions: intervention 1: Contains delta-9-tetrahydrocannabinol (THC) (25 mg/ml) and cannabidiol (CBD) (25mg/ml) as extract of Cannabis sativa L, with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg and CBD 2.5 mg). The maximum daily exposure was set at 48 actuations per day. intervention 2: Contains THC (25 mg/ml) as extract of Cannabis sativa L, with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg). The maximum daily exposure was set at 48 actuations per day. intervention 3: Contains 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. Each actuation delivered 100 μl. The maximum daily exposure was set at 48 actuations per day.

Protocol documents:
Clinical trial NCT01260896
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2002-09-01; Completion date: 2002-10-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study was to compare the rate and extent of absorption of venlafaxine hydrochloride 150 mg extended-release capsules (test) versus Effexor® XR (reference) administered as 1 x 150 mg extended-release capsule under fasting conditions.

Detailed description:

Arms: arm 1: 150 mg Venlafaxine Hydrochloride Extended-Release Capsules arm 2: 150 mg Effexor® XR Extended-Release Capsules
Interventions: intervention 1: Venlafaxine Hydrochloride intervention 2: Effexor® XR
Intervention descriptions: intervention 1: 150 mg Extended-Release Capsule intervention 2: 150 mg Extended-Release Capsule

Protocol documents:
Clinical trial NCT01282801
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2002-09-01; Completion date: 2002-10-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study was to compare the rate and extent of absorption of venlafaxine hydrochloride 150 mg extended-release capsules (test) versus Effexor® XR (reference) administered as 1 x 150 mg extended-release capsule under fed conditions.

Detailed description:

Arms: arm 1: Venlafaxine Hydrochloride 150 mg Extended-Release Capsules arm 2: Effexor® XR 150 mg Extended-Release Capsules
Interventions: intervention 1: Venlafaxine Hydrochloride intervention 2: Effexor® XR
Intervention descriptions: intervention 1: 150 mg Extended-Release Capsule intervention 2: 150 mg Extended-Release Capsule

Protocol documents:
Clinical trial NCT00950651
Conditions: Osteoarthritis, Knee Pain
Sponsor: Labopharm Inc.
Start date: 2002-03-01; Completion date: 2002-11-01
Enrollment: 431 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomised, multi-centre, double-blind, double dummy, two arm parallel design study to compare the efficacy, safety, and clinical benefit of the test and reference product after treatment for 84 days in patients with osteoarthritis of the knee.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tramadol HCl Contramid® Once A Day intervention 2: Tramadol HCl Twice a day
Intervention descriptions: intervention 1: The patients orally self-administered the study medication: either 100, 200, 300 or 400 mg Tramadol HCl Contramid® Once A Day. Each patient was titrated to his or her optimum dose (up to a maximum of 400 mg) during the Titration Phase, which lasted between 4 and 12 days. The optimum dose was taken throughout the study. intervention 2: The patients orally self-administered the study medication: either 200, 300 or 400 mg Tramadol HCl Twice a day. Each patient was titrated to his or her optimum dose (up to a maximum of 400 mg) during the Titration Phase, which lasted between 4 and 12 days. The optimum dose was taken throughout the study.

Protocol documents:
Clinical trial NCT02170077
Conditions: Epilepsy
Keywords: Epilepsy BIA 2-093
Sponsor: Bial - Portela C S.A.
Start date: 2002-04-01; Completion date: 2002-11-01
Enrollment: 144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of BIA 2 093 in the treatment of epileptic patients with refractory simple or complex partial seizures with or without secondary generalization.

Detailed description:
This clinical trial was performed as a multicentre, add-on, double-blind, randomised, placebo-controlled, phase II study. During the double-blind treatment phase (12 weeks) patients were assigned to three treatment groups receiving BIA 2 093 once daily (ODG - once-daily group), BIA 2 093 twice daily (TDG - twice-daily group) or placebo (PLG - placebo group), respectively. Daily doses of BIA 2 093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).

On completion of the 12-week double-blind treatment period, a 1-week tapering period was scheduled.

Arms: arm 1: BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg). arm 2: BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg). arm 3: placebo
Interventions: intervention 1: BIA 2-093 intervention 2: Placebo
Intervention descriptions: intervention 1: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route intervention 2: Placebo tablets administered orally

Protocol documents:
Clinical trial NCT00834808
Conditions: Healthy
Keywords: Healthy volunteers
Sponsor: Labopharm Inc.
Start date: 2002-11-01; Completion date: 2002-12-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purposes of this study were:

* To evaluate the plasma pharmacokinetic profile of tramadol and its principal metabolite, the O-desmethyltramadol, after a single oral administration of 100, 200 and 300 mg of tramadol as the Labopharm extended-release formulation prepared with Contramid.
* To assess the dose linearity of tramadol and its principal metabolite, the O-desmethyltramadol, between 100 mg and 300 mg following a single dose administration of the Labopharm extended-release formulation prepared with Contramid under fasting conditions in young healthy volunteers.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Tramadol HCl
Intervention descriptions: intervention 1: One single oral administration of Tramadol HCl 100 mg, 200 mg or 300 mg as per randomization schedule.

Protocol documents:
Clinical trial NCT00945035
Conditions: Pain
Sponsor: Organon and Co
Start date: 2002-11-01; Completion date: 2002-12-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will establish the bioequivalence of the 20%, milled, roller compaction final market image (FMI) etoricoxib tablets and 30% unmilled, roller compaction (UMC) etoricoxib tablets.

Detailed description:

Arms: arm 1: Etoricoxib, 20% tablet arm 2: Etoricoxib, 30% tablet
Interventions: intervention 1: etoricoxib intervention 2: Comparator: etoricoxib
Intervention descriptions: intervention 1: Single dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods. intervention 2: Single dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods.

Protocol documents:
Clinical trial NCT01101464
Conditions: Schizophrenia Schizoaffective Disorder
Sponsor: Organon and Co
Start date: 2002-10-01; Completion date: 2002-12-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A trial to compare if one 15 mg under the tongue tablet is equal to three 5 mg under the tongue tablets of Org 5222 (asenapine) in subjects with schizophrenia or schizoaffective disorder delivered.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Asenapine 3x5mg followed by 1x15mg intervention 2: Asenapine 1x15mg followed by 3x5mg
Intervention descriptions: intervention 1: Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days intervention 2: One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.

Protocol documents:
Clinical trial NCT00577473
Conditions: Ulcerative Colitis
Sponsor: Warner Chilcott
Start date: 2001-02-01; Completion date: 2003-02-01
Enrollment: 301 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet

Detailed description:
This study is designed to evaluate the safety and efficacy of 4.8 g/day using 800 mg Asacol tablets as compared to 2.4g/day using 400 mg Asacol tablets in newly- and previously-diagnosed patients who are experiencing a flare-up of mildly to moderately active ulcerative colitis.

Arms: arm 1: mesalamine 2.4 g/day (400 mg tablet) for 6 weeks arm 2: mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
Interventions: intervention 1: mesalamine intervention 2: mesalamine
Intervention descriptions: intervention 1: mesalamine 2.4 g/day (400 mg tablet) for 6 weeks intervention 2: mesalamine 4.8 g/day (800 mg tablet) for 6 weeks

Protocol documents: