ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01565694
Conditions: Neurogenic Detrusor Overactivity
Keywords: Cognitive Function Phase 3 Neurogenic Detrusor Overactivity Pharmacokinetics Ocular Accommodation Urodynamics
Sponsor: Astellas Pharma Europe B.V.
Start date: 2012-08-14; Completion date: 2016-04-28
Enrollment: 76 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents.

Detailed description:
The NDO often occurs in patients with spina bifida or other spinal cord damage where the bladder muscle contracts more than normal during filling. These patients often have an inability to void, so that catheterization is required to empty the bladder.

The medicine being tested in this study is called solifenacin succinate. Solifenacin tablets are given to adults for the treatment of overactive bladder. A new liquid suspension has been developed to treat children and adolescents in this and other studies.

The efficacy and safety of the solifenacin suspension was investigated. The take-up and length of time that the solifenacin suspension stays in the body was also investigated during this study. Effectiveness was measured by urodynamics (the filling and emptying of the bladder) and the urine volumes during catheterization together with the diary responses relating to the number of incontinence episodes or incontinence free days.

Safety assessments included analysis of the blood and urine, review of the electrocardiogram (ECG), ultrasound of the kidney, simple memory and understanding tests (cognitive function) and the ability to see near and far objects (visual accommodation).

Arms: arm 1: Participants aged 5 years to \< 18 years received solifenacin orally once a day, with sequential titrated doses for 12 weeks to identify the optimal dose during the dose-titration period. The initial dose was pediatric equivalent dose (PED) 5 mg.

After completing the dose titration period participants entered the fixed-dose period during which solifenacin was taken orally once a day for 40 weeks or until the end of study visit (Week 52).
Interventions: intervention 1: Solifenacin succinate
Intervention descriptions: intervention 1: Oral suspension administered once a day via syringe.

Protocol documents:
Clinical trial NCT01684878
Conditions: Ovarian Cancer
Sponsor: Hoffmann-La Roche
Start date: 2012-10-22; Completion date: 2016-04-28
Enrollment: 208 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This two-part, multicenter study will evaluate the safety, tolerability and efficacy of pertuzumab in combination with standard chemotherapy in women with recurrent platinum-resistant epithelial ovarian cancer. In the non-randomized Part 1 safety run-in, participants will receive pertuzumab plus either topotecan or paclitaxel. In the randomized, double-blind Part 2 of the study, participants will receive either pertuzumab or placebo in combination with chemotherapy (topotecan, paclitaxel, or gemcitabine).

Detailed description:

Arms: arm 1: Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. arm 2: Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. arm 3: Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion. arm 4: Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
Interventions: intervention 1: Gemcitabine (Chemotherapy) intervention 2: Paclitaxel (Chemotherapy) intervention 3: Pertuzumab intervention 4: Placebo intervention 5: Topotecan (Chemotherapy)
Intervention descriptions: intervention 1: Participants administered gemcitabine at a dosage of 1000 milligrams per square meter (mg/m\^2) intravenous (IV) infusion on Days 1 and 8 every 3 weeks. intervention 2: Participants administered paclitaxel at a dosage of 80 mg/m\^2 as 1 hour IV infusion on Days 1, 8 and 15 every 3 weeks. intervention 3: Participants administered pertuzumab 840 milligrams (mg) IV infusion on Day 1 of the first treatment cycle as a loading dose, followed by 420 mg on Day 1 of each subsequent 3 weekly cycle. intervention 4: Participants administered pertuzumab matching placebo IV infusion on Day 1 of each 3 weekly cycle. intervention 5: Participants administered topotecan at a dosage of 1.25 mg/m\^2 as a 30 minute IV infusion daily on Days 1 to 5 every 3 weeks.

Protocol documents:
Clinical trial NCT02066415
Conditions: Treatment for Prevention of Chronic Migraine
Keywords: Chronic Migraine
Sponsor: Amgen
Start date: 2014-03-05; Completion date: 2016-04-28
Enrollment: 667 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the effect of erenumab compared to placebo on the change from baseline in the number of monthly migraine days in adults with chronic migraine.

Detailed description:
This study consisted of the following phases: screening, 4-week baseline phase, 12-week double-blind treatment, and 12-week follow-up. Participants may have elected to participate in the optional pharmacokinetic substudy and the optional, novel patient-reported outcome (PRO) assessment substudy.

Participants who completed the 12-week double-blind treatment phase of Study 20120295 were eligible to enroll in an open-label extension study (Study 20130255; NCT02174861).

Arms: arm 1: Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection. arm 2: Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection. arm 3: Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Interventions: intervention 1: Erenumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered once a month subcutaneously by authorized investigational site study staff. intervention 2: Administered once a month subcutaneously by authorized investigational site study staff.

Protocol documents:
Clinical trial NCT02166476
Conditions: Urinary Tract Infection Complicated Acute Pyelonephritis
Sponsor: Melinta Therapeutics, Inc.
Start date: 2014-11-20; Completion date: 2016-04-28
Enrollment: 550 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Meropenem-vaborbactam is being compared to piperacillin-tazobactam in the treatment of adults with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP).

Detailed description:
In the current era of increased resistance to extended spectrum cephalosporins, carbapenem antimicrobial agents are frequently the antibiotics of "last defense" for the most resistant pathogens in serious infections, including those found in cUTIs. The recent dissemination of serine carbapenemases in Enterobacteriaceae in many hospitals worldwide now poses a considerable threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents.

Rempex is developing meropenem-vaborbactam administered as a fixed combination by intravenous infusion to treat serious Gram-negative infections such as cUTIs, including those infections caused by bacteria resistant to currently available carbapenems.

Arms: arm 1: Meropenem-vaborbactam (meropenem 2 grams \[g\] plus vaborbactam 2 g), infused in 250 milliliters (mL) normal saline, administered intravenously (IV) over 3 hours, every 8 hours (q8h), with 100 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-milligram (mg) dose every 24 hours (q24h) after a minimum of 15 doses of IV meropenem-vaborbactam plus saline, if clinically indicated. Total treatment was 10 days, unless a participant had baseline bacteremia where up to 14 days of therapy could be administered IV. arm 2: Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g), infused in 100 mL normal saline, administered IV over 30 minutes, q8h, with 250 mL saline administered over 30 minutes q8h. Levofloxacin tablets administered orally as a 500-mg dose q24h after a minimum of 15 doses of IV piperacillin-tazobactam plus saline, if clinically indicated. Total treatment was 10 days, unless a participant had baseline bacteremia where up to 14 days of therapy could be administered IV.
Interventions: intervention 1: Meropenem-Vaborbactam intervention 2: Piperacillin-Tazobactam intervention 3: Levofloxacin intervention 4: Saline
Intervention descriptions: intervention 1: Meropenem-vaborbactam intervention 2: Piperacillin-tazobactam intervention 3: Levofloxacin intervention 4: Saline

Protocol documents:
Clinical trial NCT02426541
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus Dapagliflozin Placebo Insulin resistance Insulin sensitivity
Sponsor: AstraZeneca
Start date: 2015-03-23; Completion date: 2016-04-28
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an 8-week, single centre, randomized, parallel-group, double-blind, placebo-controlled Phase IV study to evaluate the effect of dapagliflozin on tissue specific insulin sensitivity in patients with Type 2 diabetes mellitus

Detailed description:

Arms: arm 1: Dapagliflozin Once Daily 10 mg arm 2: Matching placebo for Dapagliflozin Once Daily 10 mg
Interventions: intervention 1: Dapagliflozin intervention 2: Placebo
Intervention descriptions: intervention 1: Dapagliflozin 10 mg Tablets, Oral, Once Daily, 8 weeks intervention 2: Matching placebo to Dapagliflozin 10 mg Tablets, Oral, Once Daily, 8 weeks

Protocol documents:
Clinical trial NCT00982865
Conditions: Solid Tumors Cancer
Keywords: MEK inhibitor Cancer Solid tumors
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2007-12-31; Completion date: 2016-04-30
Enrollment: 182 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a first in man trial with a primary objective being the determination of the Maximum Tolerated dose (MTD) and the dose-limiting toxicity (DLT) in several regimens of MEK inhibitor MSC1936369B administered orally once a day, in subjects with malignant solid tumors to see how safe is treatment with MSC1936369B.

Detailed description:

Arms: arm 1: Subjects will be administered MSC1936369B (pimasertib) capsules 1 to 120 milligram (mg) orally, once daily (QD) on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until progressive disease (PD) or intolerable toxicity or investigator/subject decision. arm 2: MSC1936369B Regimen 2 (Without Food Effect): Subjects will be administered MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.

MSC1936369B Regimen 2 (With Food Effect): : Subjects will be administered MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2. arm 3: Subjects will be administered MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. arm 4: Subjects will be administered MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Interventions: intervention 1: MSC1936369B intervention 2: MSC1936369B intervention 3: MSC1936369B intervention 4: MSC1936369B
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01973491
Conditions: Multiple Sclerosis
Keywords: ATX-MS-1467 (MSC2358825A) Relapsing Multiple Sclerosis Magnetic resonance imaging (MRI) M2736
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2014-02-28; Completion date: 2016-04-30
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-center, open-label, single arm, baseline-controlled Phase 2a trial to evaluate the clinical and biological effects of ATX-MS-1467 in subjects with relapsing multiple sclerosis (MS) and to assess the maintenance of any such effects.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: ATX-MS-1467
Intervention descriptions: intervention 1: Subjects will receive ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.

Protocol documents:
Clinical trial NCT02064816
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis, Relapsing-Remitting Interferon beta 1a Rebif®
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2014-05-31; Completion date: 2016-04-30
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, multi-center, 12-week, randomized, controlled, parallel group, Phase 4 study to assess whether the morning administration of interferon beta 1a (Rebif®) leads to a lower severity of flu-like symptoms (FLS) as compared to the evening administration, in subjects with relapsing multiple sclerosis (RMS).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rebif® intervention 2: Rebif®
Intervention descriptions: intervention 1: Rebif® will be administered at a dose of 44 microgram (mcg) subcutaneously three times a week in the morning using RebiSmart® self-injector device for 12 weeks. intervention 2: Rebif® will be administered at a dose of 44 mcg subcutaneously three times a week in the evening using RebiSmart® self-injector device for 12 weeks.

Protocol documents:
Clinical trial NCT02326220
Conditions: Heterozygous Familial Hypercholesterolemia
Sponsor: Regeneron Pharmaceuticals
Start date: 2015-03-31; Completion date: 2016-04-30
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate the effect of alirocumab 150 mg every 2 weeks (Q2W) in comparison with placebo on the frequency of low-density lipoprotein (LDL) apheresis treatments in participants with heterozygous familial hypercholesterolemia (HeFH) undergoing weekly or bi-weekly LDL apheresis therapy.

Detailed description:
LDL apheresis removes low-density lipoproteins (LDL) that transport cholesterol in the plasma portion of the blood. This treatment is mainly used for familial hypercholesterolemia, but can be used in other rare diseases. Familial hypercholesterolemia (HeFH) is an inherited genetic condition that causes accumulation of cholesterol in the blood, which can lead to atherosclerosis and heart disease. This treatment is recommended for patients who do not respond to dietary and/or medication control of LDL cholesterol.

Arms: arm 1: Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. arm 2: Alirocumab 150 mg SC injection Q2W up to Week 16. arm 3: Alirocumab 150 mg SC injection Q2W starting from Week 18 up to Week 76.
Interventions: intervention 1: Placebo intervention 2: Alirocumab
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01746979
Conditions: Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
Keywords: TH-302 Evofosfamide Pancreatic Cancer EMR200592-001
Sponsor: ImmunoGenesis
Start date: 2012-12-01; Completion date: 2016-05-01
Enrollment: 693 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 3 trial is a randomized, double-blind, placebo-controlled trial of gemcitabine in combination with TH-302 compared to gemcitabine in combination with placebo in subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma. Randomized subjects will receive TH-302 plus gemcitabine or gemcitabine plus placebo in 4-week cycles until there is evidence of progressive disease, intolerable toxicity, or the subject discontinues from the trial for other reasons (for example, withdrawal of consent). The primary efficacy endpoint is overall survival (OS) time. The data cut-off for statistical analyses of the primary and secondary endpoints will be reached when 508 events (deaths) will be reported. No planned interim analyses will be conducted. An Independent Safety Monitoring Board (ISMB) will provide periodic evaluations of the unblinded safety data to ensure subject safety and the validity and scientific merit of the study. A total of 660 subjects will be enrolled.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: TH-302 intervention 2: Gemcitabine intervention 3: Placebo (5 percent dextrose - D5W)
Intervention descriptions: intervention 1: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal. intervention 2: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal. intervention 3: TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Protocol documents:
Clinical trial NCT01845025
Conditions: Persistent Asthma
Keywords: Asthma formoterol fumarate Foradil inhaled corticosteroid fluticasone propionate safety
Sponsor: Novartis Pharmaceuticals
Start date: 2013-05-01; Completion date: 2016-05-01
Enrollment: 827 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, asthma related intubations, and asthma related deaths) in adolescents and adults (12 years of age and older) taking inhaled formoterol fumarate/fluticasone propionate combination was the same as those taking inhaled fluticasone propionate alone.

Detailed description:
This was a 26 week, double blind, randomized, active-controlled safety study of Foradil in free combination with inhaled corticosteroid versus an inhaled corticosteroid alone in adults and adolescent patients with persistent asthma. The primary objective of the study was to demonstrate that the addition of formoterol fumarate to fluticasone propionate is non-inferior to fluticasone propionate alone in terms of the risk of composite serious asthma related events (asthma-related hospitalization, asthma-related intubation, and asthma-related death). The individual components of the composite primary endpoint (i.e., asthma-related hospitalization, asthma-related intubation and asthma-related death) will be assessed as a secondary safety endpoints.

The efficacy assessment is the secondary objective.

Arms: arm 1: Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation arm 2: fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
Interventions: intervention 1: Formoterol 12 mcg intervention 2: Fluticasone propionate 100 mcg intervention 3: Fluticasone propionate 250 mcg intervention 4: Fluticasone propionate 500 mcg intervention 5: Placebo
Intervention descriptions: intervention 1: Formoterol 12 mcg one inhalation twice daily, via dry powder inhaler intervention 2: Fluticasone propionate 100 mcg one inhalation twice daily via dry powder inhaler intervention 3: Fluticasone propionate 250 mcg one inhalation twice daily via dry powder inhaler intervention 4: Fluticasone propionate 500 mcg, one inhalation twice daily via dry powder inhaler intervention 5: Placebo to match formoterol one inhalation twice daily via dry powder inhaler

Protocol documents:
Clinical trial NCT02093962
Conditions: Non-small Cell Lung Cancer
Keywords: TH-302 TH-CR-415 Pemetrexed Non-small cell lung cancer Lung cancer Evofosfamide
Sponsor: ImmunoGenesis
Start date: 2014-06-01; Completion date: 2016-05-01
Enrollment: 265 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether TH-302 in combination with pemetrexed is safe and effective in the treatment of non-squamous non-small cell lung cancer.

Detailed description:
TH-302 is designed to target the hypoxic regions of tumors which are generally located distant from tumor vessels. Pemetrexed has poor tissue penetration and targets the regions of tumors that are located in proximity to the tumor vessels. The presence of hypoxia in solid tumors is associated with a more malignant phenotype and resistance to chemotherapy. The hypoxia-activated prodrug, TH-302, is designed to selectively target the hypoxic microenvironment. There is evidence supporting the presence of hypoxia in NSCLC lesions based on a hypoxia PET study. Combining pemetrexed with TH-302 may enable the targeting of both the normoxic and hypoxic regions of NSCLC lesions.

Arms: arm 1: TH-302 in combination with pemetrexed arm 2: Matching placebo in combination with pemetrexed
Interventions: intervention 1: TH-302 combination with pemetrexed intervention 2: Matched placebo in combination with pemetrexed
Intervention descriptions: intervention 1: 400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.

Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration. intervention 2: Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.

Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration.

Protocol documents:
Clinical trial NCT02378480
Conditions: Bacterial Infections Skin Structures and Soft Tissue Infections
Sponsor: Paratek Pharmaceuticals Inc
Start date: 2015-06-01; Completion date: 2016-05-01
Enrollment: 655 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to linezolid in the treatment of adults with acute bacterial skin and skin structure infections.

Detailed description:

Arms: arm 1: Omadacycline IV; Omadacycline tablets arm 2: Linezolid IV; Linezolid tablets
Interventions: intervention 1: Omadacycline intervention 2: Linezolid
Intervention descriptions: intervention 1: Injection for IV dosing; Tablets for oral dosing intervention 2: Infusion solution for IV dosing; Tablets for oral dosing

Protocol documents: