ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01978119
Conditions: Asthma
Keywords: Multi-Dose Inhaler safety Asthma efficacy pharmacodynamics fluticasone propionate/salmeterol (FSC) 250/50 mcg tolerability Capsule-Based Inhaler
Sponsor: GlaxoSmithKline
Start date: 2013-11-06; Completion date: 2015-01-28
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a multi-centre, randomised, double-blind, double-dummy, two way cross-over, 12 week non inferiority study to evaluate the efficacy, safety, and tolerability of FSC 250/50 mcg capsule-based inhaler and FSC 250/50 mcg multi-dose inhaler each administered BID in adults and adolescents with asthma. The primary objective of this study is to demonstrate that FSC 250/50 mcg administered BID by capsule-based inhaler is non-inferior compared to FSC 250/50 mcg administered BID by multi-dose inhaler . The study consists of six phases: Pre-screening, Screening/Run-in (3 weeks), Treatment Period 1 (12 weeks), Washout (minimum 3 weeks), Treatment Period 2 (12 weeks) and Follow-up (1 week). The total duration of the study for each subject will be at least 31 weeks.

Detailed description:

Arms: arm 1: Subjects in this Arm will receive Regimen A followed by Regimen B. Regimen A: Placebo administered BID by Multi-Dose Inhaler followed by FSC (250/50 mcg) administered BID by Capsule-Based Inhaler. Regimen B: FSC (250/50 mcg) administered BID by Multi-Dose Inhaler followed by Placebo administered BID by Capsule-Based Inhaler arm 2: Subjects in this Arm will receive Regimen B followed by Regimen A. Regimen B: FSC (250/50 mcg) administered BID by Multi-Dose Inhaler followed by Placebo administered BID by Capsule-Based Inhaler. Regimen A: Placebo administered BID by Multi-Dose Inhaler followed by FSC (250/50 mcg) administered BID by Capsule-Based Inhaler
Interventions: intervention 1: FSC intervention 2: Placebo
Intervention descriptions: intervention 1: Subject will be administered FSC 250 mcg/50 mcg via dry powder inhalation device or multi-dose dry powder inhalation device BID for each treatment period intervention 2: Subject will be administered placebo via dry powder inhalation device or multi-dose dry powder inhalation device BID for each treatment period

Protocol documents:
Clinical trial NCT01502371
Conditions: Asthma
Keywords: Asthma Children Persistent
Sponsor: Organon and Co
Start date: 2012-01-25; Completion date: 2015-01-29
Enrollment: 583 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to demonstrate the dose-related efficacy, by evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent predicted forced expiratory volume in one second \[FEV1\]) across 12 weeks of treatment, of three doses (50 mcg, 100 mcg, and 200 mcg) of Mometasone Furoate (MF) Metered Dose Inhaler (MDI) twice a day (BID) compared with Placebo in children 5 to 11 years of age, inclusive, with persistent asthma. The primary hypothesis of this study is that at least one dose of MF MDI BID increases lung function, defined as a significant increase in percent predicted FEV1, when compared to Placebo.

Detailed description:

Arms: arm 1: Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks. arm 2: Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. arm 3: Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. arm 4: Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks. arm 5: Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
Interventions: intervention 1: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg intervention 2: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg intervention 3: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg intervention 4: Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg intervention 5: Placebo Metered Dose Inhaler (MDI) intervention 6: Placebo Dry Powder Inhaler (DPI)
Intervention descriptions: intervention 1: MF MDI 25 mcg (per inhalation), 2 puffs BID for 12 weeks intervention 2: MF MDI 50 mcg (per inhalation), 2 puffs BID for 12 weeks intervention 3: MF MDI 100 mcg (per inhalation), 2 puffs BID for 12 weeks intervention 4: MF DPI 100 mcg (per inhalation), 1 puff QD for 12 weeks intervention 5: Placebo MDI, 2 puffs BID for 12 weeks intervention 6: Placebo DPI, 1 puff QD for 12 weeks

Protocol documents:
Clinical trial NCT02275065
Conditions: HIV-1 Infection
Keywords: HIV-1 Infected Adults Treatment Naive
Sponsor: Gilead Sciences
Start date: 2014-10-24; Completion date: 2015-01-29
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The primary objective of the study is to investigate the short-term antiviral potency of bictegravir at multiple doses in antiretroviral (ART) treatment-naive adult participants and participants who are ART-experienced but integrase strand transfer inhibitor (INSTI) naive.

Detailed description:

Arms: arm 1: Bictegravir 5 mg (1 × 5 mg tablet) for 10 days arm 2: Bictegravir 25 mg (1 × 25 mg tablet) for 10 days arm 3: Bictegravir 50 mg (2 × 25 mg tablets) for 10 days arm 4: Bictegravir 100 mg (1 × 100 mg tablet) for 10 days arm 5: Placebo matched to bictegravir tablet for 10 days
Interventions: intervention 1: Bictegravir intervention 2: Placebo
Intervention descriptions: intervention 1: Bictegravir tablet(s) administered orally once daily intervention 2: Placebo to match bictegravir administered orally once daily

Protocol documents:
Clinical trial NCT02202161
Conditions: Diabetes Mellitus, Type 2
Keywords: pharmacokinetic intestinal bile acid transporter inhibitor metformin sitagliptin GSK2330672 pharmacodynamic
Sponsor: GlaxoSmithKline
Start date: 2014-08-27; Completion date: 2015-01-30
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of GSK2330672 compared to sitagliptin when administered with metformin for 14 days to subjects with type 2 diabetes mellitus (T2DM). Approximately 72 male and female subjects aged 30-64 years with T2DM and currently taking metformin will be recruited for this study. Eligible subjects will begin a run-in period of 13-15 days to stabilize on metformin 850 milligram (mg) twice a day (BID). Subjects will then be randomized to GSK2330672 10 mg, 20 mg, 30 mg, 90 mg, matching placebo or open-label sitagliptin 50 mg for 14 days BID. Subjects will return for a follow-up visit 7-10 days after discharge.

Detailed description:

Arms: arm 1: Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by GSK2330672 10 mg BID for 14 days. arm 2: Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by GSK2330672 20 mg BID for 14 days. arm 3: Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by GSK2330672 30 mg BID for 14 days. arm 4: Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by GSK2330672 90 mg BID for 14 days. arm 5: Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by matching placebo (of GSK2330672) BID for 14 days. arm 6: Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by Sitagliptin 50 mg BID for 14 days. In this study, sitagliptin 50 mg BID will be provided as open-label (unblinded) study treatment.
Interventions: intervention 1: GSK2330672 intervention 2: Placebo intervention 3: Sitagliptin intervention 4: Metformin
Intervention descriptions: intervention 1: GSK2330672 will be available in 10 mg, 20 mg, 30 mg, and 90 mg oral solution to be administered BID for 14 days. Subjects are to drink contents of dosing bottle (45 ml) followed by 2 x 50 ml rinses of bottle and then an additional 95 ml water for a total volume of 240 ml consumed intervention 2: Matching placebo will be available as oral solution to be administered for 14 days, BID. Subjects are to drink contents of dosing bottle (45 ml) followed by 2 x 50 ml rinses of bottle and then an additional 95 ml water for a total volume of 240 ml consumed intervention 3: Sitagliptin will be available as film-coated tablets Tablet of 50 mg to be administered orally, BID, for 14 days intervention 4: Metformin will be available as 850 mg white to off-white, film-coated tablets; to be administered BID orally during run-in through Day 14

Protocol documents:
Clinical trial NCT01703988
Conditions: Spinal Muscular Atrophy
Keywords: Spinal Muscular Atrophy SMA SMN SMNRx ISIS-SMNRx ISIS 396443
Sponsor: Biogen
Start date: 2012-10-31; Completion date: 2015-01-31
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the safety, tolerability, and pharmacokinetics of escalating doses of nusinersen (ISIS 396443) administered into the spinal fluid either two or three times over the duration of the trial, in participants with spinal muscular atrophy (SMA).

Four dose levels will be evaluated sequentially. Each dose level will be studied in a cohort of approximately 8 participants, where all participants will receive active drug.

Detailed description:
This study was conducted and the protocol was registered by Ionis Pharmaceuticals, Inc. In August 2016, sponsorship of the trial was transferred to Biogen.

Arms: arm 1: 3 mg nusinersen on Days 1, 29, 85, intrathecal (IT) injection arm 2: 6 mg nusinersen on Days 1, 29, 85, IT injection arm 3: 9 mg nusinersen on Days 1 and 85, IT injection arm 4: 12 mg nusinersen on Days 1, 29, 85, IT injection
Interventions: intervention 1: Nusinersen
Intervention descriptions: intervention 1: Single IT injection for each dose

Protocol documents:
Clinical trial NCT01741545
Conditions: Hepatitis C Virus
Sponsor: Bristol-Myers Squibb
Start date: 2013-03-31; Completion date: 2015-01-31
Enrollment: 71 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA \< LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3

Detailed description:

Arms: arm 1: Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 12 weeks

Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 12 weeks

Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks arm 2: Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 24 weeks

Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 24 weeks

Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks
Interventions: intervention 1: Pegylated-Interferon-lambda intervention 2: Ribavirin intervention 3: Daclatasvir
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01979016
Conditions: Atopic Dermatitis (AD)
Sponsor: Regeneron Pharmaceuticals
Start date: 2013-12-31; Completion date: 2015-01-31
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to assess the efficacy of Dupilumab, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).

Detailed description:

Arms: arm 1: Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection once weekly (qw) from Week 1 to Week 15. arm 2: Two subcutaneous injections of Dupilumab 200 milligram (mg) (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
Interventions: intervention 1: Dupilumab intervention 2: Placebo intervention 3: Background treatment
Intervention descriptions: intervention 1: None intervention 2: Matching placebo intervention 3: Participants were required to apply stable doses of a topical emollient (moisturizer) twice daily for at least 7 days before the baseline visit and at least 7 days after the baseline visit (day -7 to day 8).

Protocol documents:
Clinical trial NCT02088073
Conditions: Hyperkalemia
Sponsor: ZS Pharma, Inc.
Start date: 2014-03-31; Completion date: 2015-01-31
Enrollment: 258 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It is hypothesized that ZS is more effective than placebo control (alternative hypothesis) in maintaining mean double-blind randomized maintenance phase (DBRMP) Day 8-29 serum potassium levels (3.5 - 5.0 mmol/l, inclusive) among hyperkalemic subjects in whom normokalemia was established during the open-label acute phase versus no difference between each ZS dose (highest to lowest) versus placebo control (null hypothesis).

Detailed description:
Approximately 275 subjects with hyperkalemia (two consecutive i-STAT potassium levels ≥ 5.1 mmol/l, taken 60 minutes apart at baseline) will be enrolled in the Open-label Acute Phase to provide 232 subjects in the Double Blind Randomized Maintenance Phase.

Initially all subjects will receive open-label ZS at a dose of 10g three times a day (tid) for 48 hours (AP). Subjects who achieve normokalemia (i-STAT potassium values between 3.5 to 5.0 mmol/l, inclusive) on the morning of Study Day 3 (after 6 doses of 10g ZS) will then, in a double-blind fashion, be randomized 4:4:4:7 to receive one of three doses of ZS (5g, 10g or 15g) or placebo control, qd for the following 28 days (DBRMP).

Safety and tolerability will be assessed on an ongoing basis by an Independent Data Monitoring Committee (iDMC). Each active dose group in the DBRMP will consist of 49 subjects and the placebo control group will consist of 85 subjects for a total of 232 subjects to detect a 0.6 effect size difference between each ZS dose (from highest to lowest) and placebo control; the 4:4:4:7 allocation optimizes the multiple comparisons to the placebo control for the DBRMP.

Arms: arm 1: Sodium zirconium cyclosilicate 10 g three times daily for 48 hours (acute phase) arm 2: Randomized to mimic doses of experimental drug administered once daily with breakfast for 28 days. arm 3: Sodium zirconium cyclosilicate (ZS) 5 g once daily for 28 days (maintenance phase) arm 4: Sodium zirconium cyclosilicate (ZS) 10 g once daily for 28 days (maintenance phase) arm 5: Sodium zirconium cyclosilicate (ZS) 15 g once daily for 28 days (maintenance phase)
Interventions: intervention 1: Sodium zirconium cyclosilicate intervention 2: Placebo
Intervention descriptions: intervention 1: Sodium zirconium cyclosilicate intervention 2: Randomized to mimic doses of experimental drug administered once daily with breakfast for 28 days (maintenance phase)

Protocol documents:
Clinical trial NCT00809133
Conditions: Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2007-05-01; Completion date: 2015-02-01
Enrollment: 83 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
The main purpose of this study is to assess the optimum dose of the following medications when they are given together:

* BIBW 2992 and paclitaxel (Taxol)
* BIBW 2992 and paclitaxel and bevacizumab (Avastin)
* BIBW 2992 and carboplatin
* BIBW 2992 and paclitaxel and carboplatin The effect of the different drug combinations will also be assessed.

Detailed description:

Arms: arm 1: BIBW2992 + Paclitaxel arm 2: BIBW2992 + Paclitaxel + Bevacizumab arm 3: BIBW2992 + Carboplatin arm 4: BIBW2992 +Paclitaxel + Carboplatin
Interventions: intervention 1: Paclitaxel intervention 2: Carboplatin intervention 3: BIBW 2992 intervention 4: Paclitaxel intervention 5: BIBW2992 intervention 6: Paclitaxel intervention 7: Carboplatin intervention 8: Bevacizumab intervention 9: BIBW 2992 intervention 10: BIBW 2992
Intervention descriptions: intervention 1: Part A and B:80mg/m2 given on Day 1, 8 and 15 of 28 Day cycle. intervention 2: AUC6 given on day 1 of 21 day cycle intervention 3: Escalating dose cohorts intervention 4: Part A and B:80mg/m2 given on Day 1, 8 and 15 of 28 Day cycle. intervention 5: MTD dose of part A intervention 6: 175mg/m2 given on Day 1 of 21 Day cycle intervention 7: AUC6 given on day 1 of 21 day cycle intervention 8: Escalating dose Cohorts - 5mg / kg, 7.5mg / kg and 10mg / kg given Day 1 and Day 15 of a 28 days cycle intervention 9: Escalating dose cohorts intervention 10: Escalating dose cohorts

Protocol documents:
Clinical trial NCT01147250
Conditions: Acute Coronary Syndrome
Sponsor: Sanofi
Start date: 2010-06-01; Completion date: 2015-02-01
Enrollment: 6068 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

\- To demonstrate that lixisenatide can reduce cardiovascular (CV) morbidity and mortality (composite endpoint of CV death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina) compared to placebo in type 2 diabetic participants who recently experienced an acute coronary syndrome (ACS) event.

Secondary Objectives:

To demonstrate that when compared to placebo, lixisenatide can reduce:

* composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure.
* composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure.
* urinary albumin excretion (based on the urinary albumin/creatinine ratio).

To assess the safety and tolerability of lixisenatide.

Detailed description:
The estimated maximum study duration for the first randomized participant was approximately 204 weeks (± 14 days), with a median follow-up over all participants of approximately 91 weeks, broken down as follows:

* placebo-run-in period: 7 days (+ 3 days)
* double-blind study treatment period: 203 weeks (± 14 days) (with about a 37 months of recruitment period)
* post-treatment follow-up period: 3 days (± 1 day)

All participants were followed from randomization until the end of study, which should occur when the last randomized participant had been followed for approximately 10 months. The actual end date of the study was "event driven" and the study end when there were approximately 844 positively-adjudicated primary cardiovascular outcome events.

Arms: arm 1: Placebo matched to lixisenatide once daily (QD) up to end of treatment. arm 2: Lixisenatide 10 mcg QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment.
Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo
Intervention descriptions: intervention 1: Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast using self-injector pen device (Opticlik®). If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 15 or 10 mcg. intervention 2: Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast.

Protocol documents:
Clinical trial NCT01442038
Conditions: Coronary Artery Disease Angina Pectoris
Sponsor: Gilead Sciences
Start date: 2011-10-01; Completion date: 2015-02-01
Enrollment: 2651 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy of ranolazine as compared with placebo when used as part of standard medical therapy in chronic angina subjects with incomplete revascularization post-percutaneous coronary intervention (PCI; formerly known as angioplasty with stent) on the composite of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ranolazine intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will receive ranolazine 500 milligrams (mg) twice daily for 7 days, followed by 1000 mg administered orally twice daily for the duration of the study.

Subjects receiving a moderate CYP3A4 inhibitor will receive ranolazine 500 mg or placebo administered orally twice a day for the duration of the concomitant therapy. intervention 2: Subjects will receive one tablet of matching placebo twice daily for 7 days, followed by two tablets of matching placebo twice daily for the duration of the study.

Subjects receiving a moderate CYP3A4 inhibitor will receive ranolazine 500 mg or placebo administered orally twice a day for the duration of the concomitant therapy.

Protocol documents:
Clinical trial NCT01611259
Conditions: Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
Keywords: MALT Lymphoma Lenalidomide Rituximab AGMT
Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Start date: 2012-05-01; Completion date: 2015-02-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label, phase II study to evaluate the capacity of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) to induce objective responses in patients with Mucosa Associated Lymphoid Tissue (MALT) lymphoma presenting with measurable disease.

Detailed description:

Arms: arm 1: Single arm: 6 cycles for patients with complete response, 8 cycles for subjects with stable disease or partial remission; cycles duration: 28 days Rituximab (Mabthera®): 375 mg/m² i.v. day 1 Lenalidomide (Revlimid®): 20 mg p.o. daily for 21 days
Interventions: intervention 1: Rituximab and Lenalidomide
Intervention descriptions: intervention 1: Rituximab 375 mg/m² i.v. day 1 Lenalidomide 20 mg p.o. daily for 21 days Cycles should be repeated every 28 days. Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses will stop therapy/study, while patients with PR or SD will be given another two cycles for a maximum of 8 cycles.

Protocol documents: