ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01425203
Conditions: Chronic Hepatitis C Genotype 1
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-11-23; Completion date: 2013-10-21
Enrollment: 238 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) \[PEG+RBV=PR\] is effective in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The primary hypothesis is that the percentage of participants achieving sustained virologic response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group.

Detailed description:

Arms: arm 1: Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks. arm 2: Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks. arm 3: Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR.
Interventions: intervention 1: Boceprevir intervention 2: Placebo intervention 3: peginterferon alfa-2b intervention 4: Ribavirin
Intervention descriptions: intervention 1: boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO) intervention 2: boceprevir-matched placebo four 200-mg capsules PO TID. intervention 3: peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC) intervention 4: ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).

Protocol documents:
Clinical trial NCT01371994
Conditions: Urinary Incontinence
Keywords: Radical Robotic Arm Vesicare Post Prostatectomy Incontinence YM905
Sponsor: Astellas Pharma Inc
Start date: 2011-08-02; Completion date: 2013-10-21
Enrollment: 640 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment of solifenacin succinate versus placebo in participants who are incontinent after Robotic Assisted Radical Prostatectomy.

This study will also assess the effect of 12 weeks of treatment with solifenacin succinate versus placebo on quality of life (QOL) as measured by questionnaires.

Detailed description:
The study duration includes a 14-day treatment free wash-out period. The maximum total study duration is 15 weeks (2-3 week screening/washout period and a 12 week treatment period). The Baseline, Week 4, and Week 8 visits will be telephone contact visits.

Participants will complete an electronic daily pad use diary during the study

duration. Participants will also be asked to complete several questionnaires during the study.

Arms: arm 1: Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily. arm 2: Participants received matching placebo tablets once a day for 12 weeks.
Interventions: intervention 1: solifenacin succinate intervention 2: Placebo
Intervention descriptions: intervention 1: oral intervention 2: oral

Protocol documents:
Clinical trial NCT01709318
Conditions: Contraception
Sponsor: Organon and Co
Start date: 2012-12-12; Completion date: 2013-10-22
Enrollment: 666 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this trial was to identify at least one next generation ring (NGR) that demonstrates inhibition of ovulation (which was considered confirmed if in the subset of participants ovulation was observed in less than 15% of the participants at any time during the 3 treatment cycles of the study) and cycle control that was non-inferior to NuvaRing®, as judged by the incidence of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3. The primary hypothesis was that at least 1 of the 6 NGRs would show inhibition of ovulation and cycle control during Treatment Cycle 3 that is non-inferior to NuvaRing®, as judged by the incidence of BTB-S.

Detailed description:

Arms: arm 1: Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. arm 2: Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. arm 3: Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. arm 4: Participants will receive etonogestrel 17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. arm 5: Participants will receive etonogestrel 17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. arm 6: Participants will receive etonogestrel 17β-estradiol (ENG-E2)125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. arm 7: Participants will receive NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
Interventions: intervention 1: Nomegestrol acetate (NOMAC) intervention 2: Etonogestrel (ENG) intervention 3: Ethinyl estradiol (EE) intervention 4: Estradiol (E2)
Intervention descriptions: intervention 1: Daily release of 500, 700, or 900 μg. intervention 2: Daily release of 75, 100, 120 or 125 μg intervention 3: Daily release of 15 μg intervention 4: Daily release of 300 μg

Protocol documents:
Clinical trial NCT01316939
Conditions: Crohn's Disease
Keywords: Crohn's disease, oral CCR9 antagonist, placebo-controlled, maintenance of remission, 52-week treatment, quality of life
Sponsor: GlaxoSmithKline
Start date: 2011-05-09; Completion date: 2013-10-23
Enrollment: 229 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK sponsored induction study. The primary endpoint will be proportion of subjects in remission at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical laboratory parameters including liver function tests, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and disability.

Detailed description:
This is a multi-centre, randomised, placebo-controlled, double-blind parallel group study in adult subjects with Crohn's disease who previously achieved clinical response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior Phase III induction study (Study CCX114151 or another GSK sponsored induction study). Subjects will be randomised to 52 weeks of oral treatment with GSK1605786A 500 mg once daily or 500 mg twice daily or placebo. Subjects who are receiving concomitant corticosteroids at entry will undergo dose tapering following a defined schedule. Subjects who complete the treatment period may be eligible to enter an open-label extension study. Subjects who experience disease worsening and require additional (rescue) treatment will be withdrawn and may be eligible to enter the open-label study. Subjects who do not enter the open-label study must complete a follow-up assessment 4 weeks after completion of treatment. Approximately 756 subjects will be enrolled.

Arms: arm 1: Placebo arm 2: 500 milligrams once daily arm 3: 500 milligrams twice daily
Interventions: intervention 1: GSK1605786A intervention 2: Placebo intervention 3: GSK1605786A
Intervention descriptions: intervention 1: GSK1605786A 500 milligrams once daily intervention 2: Placebo intervention 3: GSK1605786A 500 milligrams twice daily

Protocol documents:
Clinical trial NCT01618162
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2012-08-29; Completion date: 2013-10-23
Enrollment: 435 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. All subjects will continue their pre-trial SU treatment with or without metformin treatment without changing the frequency or dose throughout the trial.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/liraglutide intervention 2: placebo
Intervention descriptions: intervention 1: Injected subcutaneously (under the skin) once daily. Dose individually adjusted. intervention 2: Injected subcutaneously (under the skin) once daily.

Protocol documents:
Clinical trial NCT01147926
Conditions: Male Subjects With Chronic Constipation
Keywords: Constipation Male
Sponsor: Shire
Start date: 2010-09-23; Completion date: 2013-10-25
Enrollment: 374 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-centre, randomised, parallel-group, double-blind, placebo-controlled phase III trial to evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation.

Furthermore the safety, tolerability, effect on quality of life and effect on symptoms of prucalopride will be assessed.

Detailed description:
In this phase III trial subjects will be screened and enter a 2-week run-in period (or a 3-week run-in period if the subject is using agents that influence bowel habit) during which the presence of constipation will be confirmed \[the subject will complete an electronic daily diary (e-diary)\]. At the start of run-in, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial. Subjects will be allowed to take a laxative \[Dulcolax (bisacodyl)\] as rescue medication during the trial, but only if they have not had a bowel movement (BM) for 3 or more consecutive days. An enema can only be used after unsuccessful use of Dulcolax (bisacodyl). No Dulcolax (bisacodyl) should be taken or enemas used between 48 hours before and 48 hours after the first intake of study medication.

After the run-in subjects will be randomly assigned to placebo or prucalopride in an equal ratio (1:1) if the subject fulfils the constipation criteria for inclusion. Randomisation will be stratified by country and by the average number of complete bowel movements (CBM) during run-in: 0 CBM/week and \> 0 CBM/week.

Adult subjects (i.e. subjects ≥18 to \<65 years of age) will take 2 mg prucalopride or matching placebo once daily before breakfast during the entire 12-week treatment period. Elderly subjects (i.e. subjects ≥65 years of age) will start at a dose of 1 mg prucalopride or matching placebo once daily before breakfast. In case of insufficient response, defined as an average of \<3 spontaneous complete bowel movements (SCBM)/week during the preceding 2 weeks of treatment (i.e. since the previous visit) at Week 2 or Week 4, the daily dose has to be increased to 2 mg (or matching placebo). Once the dose is increased to 2 mg once daily the subject will stay on this dose for the remainder of the trial. After Week 4 (Visit 4) no changes in dose are allowed anymore.

Arms: arm 1: Placebo arm 2: 1 milligram (mg) or 2 mg
Interventions: intervention 1: Placebo intervention 2: Prucalopride
Intervention descriptions: intervention 1: Placebo matched to Prucalopride tablet orally once daily. intervention 2: Prucalopride 2 mg tablet orally once daily for subjects greater than or equal to (≥) 18 to less than (\<) 65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.

Protocol documents:
Clinical trial NCT01817764
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: umeclidinium bromide (UMEC) vilanterol (VI) salmeterol (SAL) fluticasone propionate (FP) Novel Dry Powder Inhaler (NDPI) Chronic obstructive pulmonary disease GW642444 GSK573719 lung function
Sponsor: GlaxoSmithKline
Start date: 2013-03-01; Completion date: 2013-10-25
Enrollment: 707 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with COPD. Subjects who meet the eligibility criteria at Screening will complete a 7 to 14 day Run-in period. At the end of the run-in period, approximately 710 eligible subjects will be equally randomized (to complete at least 568 evaluable subjects) to one of the 2 treatment groups for 12 weeks: 1. UMEC/VI 62.5/25 micrograms (mcg) administered as one inhalation once-daily in the morning via the Novel dry powder inhaler (NDPI) + placebo administered as one inhalation each morning and evening via single multidose powdered inhaler (ACCUHALER/DISKUS) or 2. FSC 250/50 mcg administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once-daily in the morning via NDPI. A safety Follow-up assessment will be conducted approximately 7 days after the end of the study treatment (Early Withdrawal, if applicable). The total duration of subject participation will be approximately 15 weeks.

Detailed description:

Arms: arm 1: The subjects will receive UMEC/VI 62.5/25 mcg, administered as one inhalation once-daily in the morning via the NDPI and placebo administered as one inhalation each morning and evening via ACCUHALER/DISKUS arm 2: The subjects will receive FSC 250/50 mcg, administered as one inhalation each morning and evening via ACCUHALER/DISKUS and placebo administered once-daily in the morning via NDPI
Interventions: intervention 1: Umeclidinium/vilanterol intervention 2: Fluticasone propionate/salmeterol intervention 3: Placebo
Intervention descriptions: intervention 1: Dry white powder delivered via NDPI (2 strips with 30 blisters each, first containing UMEC 62.5 mcg per blister and second containing VI 25 mcg per blister), administered as one inhalation of UMEC/VI 62.5/25 mcg once-daily in the morning intervention 2: Dry white powder delivered via ACCUHALER/DISKUS (1 strip with 60 blisters, containing 250 mcg fluticasone propionate and 50 mcg salmeterol per blister), administered as one inhalation of FSC 250/50 mcg each morning and evening intervention 3: Placebo will be administered via ACCUHALER/DISKUS or NDPI. Dry white powder administered as one inhalation each morning and evening via ACCUHALER/DISKUS (1 strip with 60 blisters containing placebo) OR once-daily in the morning via NDPI (2 strips with 30 blisters each, containing placebo)

Protocol documents:
Clinical trial NCT00626197
Conditions: Lupus Nephritis Systemic Lupus Erythematosus
Keywords: SLE Lupus BELONG
Sponsor: Genentech, Inc.
Start date: 2008-02-15; Completion date: 2013-10-28
Enrollment: 381 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase III, randomized, double-blind, placebo-controlled, multicentre, parallel-group study designed to evaluate the efficacy and safety of ocrelizumab added to SOC (corticosteroid plus one of two immunosuppressant regimens) compared with placebo added to SOC in patients with WHO or ISN Class III or IV lupus nephritis.

Detailed description:

Arms: arm 1: Participants received Ocrelizumab 400 mg i.v. infusion on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks plus SOC regimen. arm 2: Participants received Ocrelizumab 1000 mg i.v. infusion on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks plus SOC regimen. arm 3: Participants received placebo i.v. infusion on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks plus SOC regimen.
Interventions: intervention 1: Corticosteroids intervention 2: Cyclophosphamide intervention 3: Mycophenolate Mofetil intervention 4: Ocrelizumab intervention 5: Placebo intervention 6: Azathioprine
Intervention descriptions: intervention 1: Intravenous and oral repeating dose intervention 2: Cyclophosphamide was administered at a IV dose 500 mg every 2 weeks for up to 6 doses followed by maintenance treatment with azathioprine. intervention 3: Mycophenolate Mofetil was administered orally at maximum dose of 3 g/day. intervention 4: Ocrelizumab was administed at a dose and as per schedule in arm description intervention 5: Placebo was administered as per schedule in arm description intervention 6: Azathioprine was administered at a dose up to 2 mg/kg/day with a maximum dose of 200 mg.

Protocol documents:
Clinical trial NCT00993187
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-05-04; Completion date: 2013-10-29
Enrollment: 292 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the effect of sitagliptin/metformin FDC 50/1000 mg (Janumet®), MK-0431A) compared with the effect of glimepiride on hemoglobin A1c (HbA1c). The primary hypothesis is that after 30 weeks, sitagliptin/metformin FDC 50/1000 mg provides superior reduction in HbA1c (mean change from baseline) compared to glimepiride.

Detailed description:

Arms: arm 1: Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks. arm 2: Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
Interventions: intervention 1: Sitagliptin/Metformin FDC intervention 2: Comparator: Glimepiride intervention 3: Matching placebo to Sitagliptin/Metformin FDC intervention 4: Matching placebo to glimepiride
Intervention descriptions: intervention 1: Sitagliptin phosphate plus metformin hydrochloride combination tablet (MK-0431A) orally up to 50/1000 mg BID for 30 weeks intervention 2: Glimepiride tablet orally up to 6 mg daily for 30 Weeks intervention 3: Matching placebo to Sitagliptin/Metformin FDC 50/1000 mg orally BID for 30 weeks intervention 4: Matching placebo to glimepiride tablet orally daily for 30 weeks

Protocol documents:
Clinical trial NCT01763827
Conditions: Hyperlipidemia
Keywords: High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
Sponsor: Amgen
Start date: 2013-01-21; Completion date: 2013-10-29
Enrollment: 615 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.

Detailed description:

Arms: arm 1: Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. arm 2: Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. arm 3: Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. arm 4: Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. arm 5: Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. arm 6: Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
Interventions: intervention 1: Evolocumab intervention 2: Ezetimibe intervention 3: Placebo to Evolocumab intervention 4: Placebo to Ezetimibe
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered orally once a day intervention 3: Administered by subcutaneous injection intervention 4: Administered orally once daily

Protocol documents:
Clinical trial NCT01121536
Conditions: Depression
Keywords: Bipolar I Disorder
Sponsor: Cephalon
Start date: 2010-04-30; Completion date: 2013-10-31
Enrollment: 867 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder.

Detailed description:

Arms: arm 1: Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
Interventions: intervention 1: Armodafinil
Intervention descriptions: intervention 1: Armodafinil tablets, taken orally, once daily in the morning

Protocol documents: