ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01462344
Conditions: Asthma
Keywords: pediatric ADVAIR FLOVENT asthma
Sponsor: GlaxoSmithKline
Start date: 2011-11-17; Completion date: 2015-11-03
Enrollment: 6250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.

Detailed description:
Progress of Enrollment, Updated Annually: This study has been completed and the final clinical study report was submitted to the FDA in May of 2016. This is the final update, as this study is complete.

Arms: arm 1: fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months arm 2: fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months arm 3: fluticasone propionate (100) twice daily (AM and PM) for 6 months arm 4: fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
Interventions: intervention 1: ADVAIR 100/50mcg intervention 2: ADVAIR 250/50mcg intervention 3: FLOVENT 100mcg intervention 4: FLOVENT 250mcg
Intervention descriptions: intervention 1: fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months intervention 2: fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months intervention 3: fluticasone propionate (100) twice daily (AM and PM) for 6 months intervention 4: fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months

Protocol documents:
Clinical trial NCT01406717
Conditions: Type 2 Diabetes Mellitus
Keywords: SPIL1033 type 2 diabetes mellitus
Sponsor: Sun Pharmaceutical Industries Limited
Start date: 2013-03-01; Completion date: 2015-11-04
Enrollment: 360 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
SPIL1033 resembles a gut hormone, which increases the insulin secretion, thus helps in reducing blood glucose levels. The purpose of study is to establish safety and efficacy of SPIL1033

Detailed description:
SPIL1033 is subcutaneous injection is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus.

In this study, efficacy and safety of SPIL1033 will be evaluated. Subjects will receive SPIL1033 or placebo, 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SPIL1033 intervention 2: Placebo
Intervention descriptions: intervention 1: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. intervention 2: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.

Protocol documents:
Clinical trial NCT01451606
Conditions: Pelvis Pain Chronic
Keywords: Chronic Pelvic Pain (CPP) Pelvic Pain
Sponsor: University of Maryland, Baltimore
Start date: 2011-07-11; Completion date: 2015-11-04
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is examining the effectiveness of duloxetine as a treatment for chronic pelvic pain in women. Duloxetine is FDA approved for the treatment of other pain conditions, including fibromyalgia and diabetic neuropathy.

Detailed description:
Chronic pelvic pain in women can be caused by various pathologies, such as endometriosis, fibroids, and adhesions. Surgical treatment of the pathology often relieves the pain, but a significant number of women continue to have pain, even after visibly successful surgery. One model explored in this study is that in some cases of chronic pelvic pain, the central nervous system has changed in its processing of pain-related signals, requiring a therapy directed to the Central Nervous System (CNS) to effectively treat the pain. This model has been supported in studies of other chronic pain conditions, such as fibromyalgia and migraine. This study will seek to determine whether the analgesic effectiveness of duloxetine is related to the pain state of the individual.

Arms: arm 1: A pill that looks like the active drug, but does not contain any active ingredients. arm 2: The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).
Interventions: intervention 1: Duloxetine intervention 2: Placebo
Intervention descriptions: intervention 1: 30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week intervention 2: To serve as placebo for duloxetine. Administration schedule same as for active drug.

Protocol documents:
Clinical trial NCT01646125
Conditions: Advanced Non Small Cell Lung Cancer (NSCLC)
Keywords: Non-small cell lung carcinoma (NSCLC) treatment of lung cancer after first metastasis lung cancer lung adenocarcinoma Squamous cell lung carcinoma Large-cell lung carcinoma Non small cell lung carcinoma Non small cell lung cancer Non-small cell lung cancer NSCLC Large cell lung carcinoma Large cell lung cancer HSP90 AUY922 Pemetrexed Docetaxel EGFR TKI EGFR mutations
Sponsor: Novartis Pharmaceuticals
Start date: 2012-11-23; Completion date: 2015-11-04
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine if AUY922 had superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations.

The primary purpose of this study was to compare the efficacy of AUY922, when administered i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed resistance to EGFR TKI.

Detailed description:

Arms: arm 1: Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.

AUY922 was to be administered weekly. arm 2: Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.

Pemetrexed or docetaxel was to be was to be given once every three weeks.
Interventions: intervention 1: AUY922 intervention 2: Docetaxel intervention 3: Pemetrexed
Intervention descriptions: intervention 1: AUY922 was to be given by i.v. once weekly at 70 mg/m2 until disease progression, death or any other reason for discontinuation from study treatment. intervention 2: Docetaxel was to be given i.v. once every 3 weeks at 75 mg/m2 until progression or unacceptable toxicity intervention 3: Pemetrexed was to be given once every 3 weeks at 500 mg/m2 until progression or unacceptable toxicity

Protocol documents:
Clinical trial NCT01945294
Conditions: Hepatitis C, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-10-10; Completion date: 2015-11-04
Enrollment: 257 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to estimate the difference in the efficacy between a 16-week treatment regimen of boceprevir (BOC) in combination with peg-intron alpha 2b (P) plus ribavirin (R) (BOC + PR) and a 28-week treatment regimen of BOC + PR in previously untreated participants with chronic hepatitis C (CHC) genotype 1 in Asia who achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA).

Detailed description:

Arms: arm 1: All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28). arm 2: All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40). arm 3: All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
Interventions: intervention 1: Boceprevir intervention 2: Peg-interferon alfa-2b intervention 3: Ribavirin
Intervention descriptions: intervention 1: 800 mg three times daily orally intervention 2: 1.5 mcg/kg weekly subcutaneously intervention 3: 800-1400 mg twice-daily divided orally based on body weight

Protocol documents:
Clinical trial NCT02336503
Conditions: Hyperhidrosis
Sponsor: Botanix Pharmaceuticals
Start date: 2015-03-10; Completion date: 2015-11-05
Enrollment: 189 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the safety and efficacy of 3 doses of BBI-4000 and vehicle (4 treatment arms), when applied once a day for 4 weeks, for the treatment of axillary hyperhidrosis.

Detailed description:
This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 3 concentrations of Topically Applied BBI-4000 in Subjects with Axillary Hyperhidrosis.

Participating subjects will apply BBI-4000 once a day for 4 weeks in their axillae. The 4 week treatment period will be followed by a 2 week follow-up period.

Safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology and serum chemistry laboratory testing and ECGs.

Efficacy will be assessed using the Hyperhidrosis Disease Severity Scale (patient reported outcome) and through gravimetrically measured sweat production.

PK blood samples will be taken from study subjects from selected centers.

Arms: arm 1: Low concentration of BBI-4000; BBI-4000 Gel, 5% arm 2: Middle concentration of BBI-4000; BBI-4000 Gel, 10% arm 3: High concentration of BBI-4000; BBI-4000 Gel, 15% arm 4: Vehicle (placebo); BBI-4000 Gel, 0%
Interventions: intervention 1: BBI-4000 Gel, 5% intervention 2: BBI-4000 Gel, 10% intervention 3: BBI-4000 Gel, 15% intervention 4: Vehicle
Intervention descriptions: intervention 1: BBI-4000 Gel, 5% intervention 2: BBI-4000 Gel, 10% intervention 3: BBI-4000 Gel, 15% intervention 4: Placebo, BBI-4000 Gel, 0%

Protocol documents:
Clinical trial NCT01113502
Conditions: Acute Myelogenous Leukemia (AML)
Sponsor: Abramson Cancer Center at Penn Medicine
Start date: 2010-06-01; Completion date: 2015-11-10
Enrollment: 44 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase I/II open label study being conducted to evaluate the overall safety and initial effectiveness of an investigational drug, Eltrombopag in patients who are 60 years of age and older and who have Acute Myelogenous Leukemia (AML). Eltrombopag is an investigational drug, which means it has not been approved by the U.S. Food and Drug Administration (FDA) for use in this type of disease. Approximately 35 people will be enrolled on this study at the University of Pennsylvania

Detailed description:
Primary Objectives (Phase I Portion): 1). To determine the safety and tolerability of eltrombopag in elderly subjects with AML 2). To determine the maximally tolerated initial starting dose of eltrombopag for elderly subjects with AML Primary Objectives (Phase II portion): 1). To better define the safety and tolerability of eltrombopag in elderly patients with AML at the maximally tolerated starting dose Page 9 of 18 determined in Phase I portion of study. 2). To determine the incidence of peripheral platelet count improvement (using baseline and response parameters as defined below) for subjects with disease related thrombocytopenia. Secondary Objectives (Phase I and II): 1). To preliminarily determine the efficacy (using AML response criteria as defined below) of eltrombopag in elderly subjects with AML.

2). To perform ex-vivo analyses using subject AML samples and stock eltrombopag to 1) assess leukemic proliferative capacity and 2) investigate potential eltrombopag induced cytoxic mechanisms for leukemic cell death. 3). To perform pharmacodynamic assessments of drug activity in leukemic cells using subject samples collected at various time points before and during drug exposure. 4). To preliminarily correlate pharmacodynamic findings with clinical response.

Arms: arm 1: 50 mg; Taken daily by mouth arm 2: 100 mg; Taken daily by mouth arm 3: 200 mg; Taken daily by mouth arm 4: 300 mg; Taken daily by mouth arm 5: 200 mg taken daily by mouth for 2 weeks; then 300 mg taken daily by mouth
Interventions: intervention 1: Eltrombopag
Intervention descriptions: intervention 1: Oral formulation taken daily

Protocol documents:
Clinical trial NCT02138747
Conditions: Overactive Bladder (OAB)
Keywords: Overactive bladder (OAB) tolterodine ER mirabegron
Sponsor: Astellas Pharma Global Development, Inc.
Start date: 2014-07-24; Completion date: 2015-11-11
Enrollment: 376 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study was to assess tolerability of mirabegron compared to tolterodine ER in the treatment of participants with symptoms of Overactive Bladder (OAB) as well as the impact of treatment on micturition frequency and incontinence episodes.

Detailed description:
The study consisted of two double-blind treatment periods with a wash-out period in between.

Arms: arm 1: In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period. arm 2: In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period. arm 3: In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period. arm 4: Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
Interventions: intervention 1: Mirabegron intervention 2: Tolterodine ER
Intervention descriptions: intervention 1: Oral intervention 2: Oral

Protocol documents:
Clinical trial NCT02254291
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2014-10-02; Completion date: 2015-11-11
Enrollment: 308 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Japan. The purpose is to compare the safety of once-weekly dosing of semaglutide (0.5 and 1.0 mg) versus sitagliptin (100 mg) once daily, both as monotherapy during 30 weeks of treatment in Japanese subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: semaglutide intervention 2: semaglutide intervention 3: sitagliptin
Intervention descriptions: intervention 1: Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks). Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin). intervention 2: Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks) followed by 0.5 mg for 4 weeks. Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin). intervention 3: Daily doses of 100 mg sitagliptin. Total duration of treatment is 30 weeks. Administered as oral tablets.

Protocol documents:
Clinical trial NCT02059161
Conditions: Type 1 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-10-17; Completion date: 2015-11-12
Enrollment: 508 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and efficacy of MK-1293 to Lantus™ in participants with T1DM. The primary hypothesis is that after 24 weeks, the mean change in hemoglobin A1c (A1C) from baseline is non-inferior in participants treated with MK-1293 compared with participants treated with Lantus™.

Detailed description:

Arms: arm 1: MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post randomization to the suggested target for fasting fingerstick glucose levels of \>70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L). arm 2: Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of \>70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
Interventions: intervention 1: MK-1293 intervention 2: Lantus™ intervention 3: Prandial Insulin
Intervention descriptions: intervention 1: MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Initial dose will be determined based on the participant's previous insulin therapy. Thereafter, the dose will be titrated to the suggested target for fasting fingerstick glucose levels. MK-1293 dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time. intervention 2: Lantus™ dosed subcutaneously once daily at bedtime for 52 weeks. Initial dose will be determined based on the participant's previous insulin therapy. Thereafter, the dose will be titrated to the suggested target for fasting fingerstick glucose levels. Lantus™ dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time. intervention 3: Participants will continue their prandial insulin during the study.

Protocol documents:
Clinical trial NCT01399593
Conditions: Antibody Mediated Rejection
Keywords: Antibody Mediated Rejection AMR Acute Humoral Rejection AHR Living Donor Kidney Transplant
Sponsor: Alexion Pharmaceuticals, Inc.
Start date: 2011-11-02; Completion date: 2015-11-13
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant requiring desensitization therapy.

Detailed description:
The main objective of this study was to evaluate the safety and efficacy of eculizumab to prevent AMR in sensitized recipients of living donor kidney transplants requiring desensitization therapy prior to transplantation. The primary endpoint focused on acute AMR during the first 9 weeks post-transplantation.

Patients were to be vaccinated against N. meningitidis at least 14 days prior to study drug initiation and revaccinated 30 days later. If not vaccinated 14 days prior, prophylactic antibiotics were to be administered. Pre-transplant infectious disease assessment was to be performed as part of the screening assessment.

Patients were to undergo desensitization therapy according to the practice of the local transplant center prior to transplantation, and this desensitization practice was to be uniformly applied for all patients at that center throughout the study. The actual length of desensitization for an individual patient was based on the clinical judgment of the Transplant Center team. Rituximab was prohibited in all patients as part of the pre-transplantation desensitization therapy due to potential pharmacodynamic interactions.

The control group was designed to test eculizumab against the best available care (referred to as standard of care, or SOC) consisting of plasmapheresis (PP) and/or intravenous immunoglobulin (IVIg). The best available care consisting of PP and IVIg was chosen because these modalities combined represented the most prevalent therapy reported in the literature and were the best available therapies at the time of this protocol's inception as per the transplant community.

Arms: arm 1: Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously: the median infusion time was 39 minutes. arm 2: Patients received standard of care (SOC) prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
Interventions: intervention 1: Eculizumab
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02076100
Conditions: Hepatitis C Infection
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-03-27; Completion date: 2015-11-15
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 3-part study of Ruzasvir (MK-8408) for participants with hepatitis C infection. Successive participants will be enrolled as dose levels are evaluated to find the maximum safe and well tolerated dose of Ruzasvir. Part I will be for participants with hepatitis C virus (HCV) genotype 3 (GT3) and will run first: Part II will be for participants with HCV genotype 1a (GT1a), and Part III will be for participants with HCV genotype 2b (GT2b). Parts II and III may run concurrently. The primary study hypothesis is that a safe and tolerable dose of Ruzasvir that reduces viral load will be found to support further clinical investigation.

Detailed description:

Arms: arm 1: Participants receive Ruzasvir capsules, orally, starting at a dose of 60 mg once per day (QD) x 5 days with doses increasing or decreasing as clinically indicated. arm 2: Participants receive Ruzasvir capsules, orally, starting at a dose of 60 mg once per day (QD) x 5 days with doses increasing or decreasing as clinically indicated. arm 3: Participants receive Ruzasvir capsules, orally, starting at a dose of 60 mg once per day (QD) x 5 days with doses increasing or decreasing as clinically indicated.
Interventions: intervention 1: Ruzasvir
Intervention descriptions: intervention 1: Ruzasvir capsules, orally, starting at a dose of 60 mg once per day (QD) x 5 days with doses increasing or decreasing as clinically indicated.

Protocol documents: