ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02207946
Conditions: Essential Tremor of the Upper Limbs
Sponsor: Merz Pharmaceuticals GmbH
Start date: 2014-12-05; Completion date: 2016-09-26
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the efficacy and safety of a single, kinematic-analysis-based intramuscular injection of NT 201, compared with placebo, in moderate to marked essential tremor of the upper limb.

Detailed description:

Arms: arm 1: Single injection cycle, total dose of up to 200 Units, intramuscular injection into muscles of wrist (mandatory) and shoulder and/or elbow (both optional). arm 2: Single injection cycle, intramuscular injection into muscles of wrist (mandatory) and shoulder and/or elbow (both optional).
Interventions: intervention 1: IncobotulinumtoxinA intervention 2: Placebo
Intervention descriptions: intervention 1: Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). intervention 2: Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Protocol documents:
Clinical trial NCT02442271
Conditions: Chronic Hepatitis C Infection
Keywords: Chronic Hepatitis C Hepatitis C Treatment Naive Hepatitis C Genotype 1 Hepatitis C Treatment Experienced Hepatitis C Virus
Sponsor: AbbVie
Start date: 2015-04-27; Completion date: 2016-09-26
Enrollment: 222 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs; ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.

Detailed description:

Arms: arm 1: 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir and dasabuvir intervention 2: ribavirin
Intervention descriptions: intervention 1: Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet intervention 2: Tablet

Protocol documents:
Clinical trial NCT02512575
Conditions: Safety Tolerability Pharmacokinetics Pharmacodynamics Healthy Subjects Rheumatoid Arthritis
Keywords: AZD9567 Healthy subjects Phase 1 placebo controlled single ascending dose Pharmacokinetics Pharmacodynamics Rheumatoid Arthritis
Sponsor: AstraZeneca
Start date: 2015-11-18; Completion date: 2016-09-26
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase I, first-in-human (FIH), randomized, single-blind, placebo-controlled, single ascending dose sequential group study in healthy male subjects. The objectives are to study the safety, tolerability, pharmacokinetics and effects on glucose homeostasis (pharmacodynamics) of AZD9567, an oral differentiated non-steroidal selective glucocorticoid receptor modulator (SGRM). The study will also assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of prednisolone 60 mg in comparison with high doses of AZD9567 and placebo.

Detailed description:
This is a Phase I, first-in-human (FIH), randomized, single-blind, placebo-controlled, single ascending dose sequential group study in healthy male subjects. The objectives are to study the safety, tolerability, pharmacokinetics and effects on glucose homeostasis (pharmacodynamics) of AZD9567. Additional exploratory variables (Inflammation biomarkers, ECG modelling and taste assessment) will also be evaluated. The study will also assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of prednisolone 60 mg in comparison with high doses of AZD9567 and placebo. The study will be conducted at a single study centre with a planned number of subjects of up to 72 healthy males, aged 18 to 55 years.

Arms: arm 1: In Part A: up to 8 cohorts with single ascending doses (starting at 2 mg up to 155 mg).

In Part B: one cohort with a single dose arm 2: Subjects randomized to placebo in the first 8 cohorts will receive the same dose volume of oral suspension as subjects on AZD9567 and subjects randomized to placebo in cohort 9(prednisolone cohort) will receive the same number of capsules as subjects on prednisolone. arm 3: Within each cohort 6 subjects will be randomized to receive prednisolone 60mg oral capsules and 2 subjects randomized to receive matching placebo in a fasted state.

Sentinel dosing will not be employed for the prednisolone cohort. The SRC will not be required to evaluate the prednisolone cohort. This cohort can be performed at any time during clinical execution of the study provided the protocol amendment was approved.
Interventions: intervention 1: AZD9567 Monohydrat intervention 2: Placebo oral suspension/ Placebo capsule intervention 3: Prednisolone
Intervention descriptions: intervention 1: AZD9567 oral suspension 0.5 to 10 mg/ml intervention 2: Matching placebo intervention 3: Prednisolone 60mg oral capsules (12 capsules of 5 mg each).

Protocol documents:
Clinical trial NCT02421094
Conditions: Nonalcoholic Steatohepatitis
Sponsor: Galectin Therapeutics Inc.
Start date: 2015-09-01; Completion date: 2016-09-27
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Randomized, Controlled, Double-blind, Parallel Group, Single Center Phase 2 Clinical Trial to Evaluate Multiple Non-Invasive Liver Fibrosis Imaging Methods in the Assessment of the Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis in Patients with NASH with Advanced Fibrosis

Detailed description:
The primary objective is to determine the difference between placebo and GR-MD-02 treatment in the baseline adjusted mean change in liver fibrosis as measured by corrected T1 (cT1) mapping as determined from LiverMultiScan (LMS), a multi-parametric MRI protocol.

Secondary objectives include evaluating differences between subjects treated with GR-MD-02 versus placebo in:

* The baseline-adjusted change in liver stiffness as measured by MR-elastography
* The baseline-adjusted change in liver stiffness as measured by FibroScan® scores.

An exploratory objective will be to evaluate the correlation of the three diagnostic modalities of LiverMultiScan, MR-Elastography, and FibroScan®.

Arms: arm 1: Active arm 2: Placebo
Interventions: intervention 1: GR-MD-02 intervention 2: Placebo
Intervention descriptions: intervention 1: GM-MD-02 active intervention 2: Placebo

Protocol documents:
Clinical trial NCT01986855
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-12-02; Completion date: 2016-09-28
Enrollment: 468 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in participants with Type 2 diabetes mellitus with Stage 3 Chronic Kidney Disease (CKD) who have inadequate glycemic control on background antihyperglycemic therapy. The duration of this trial will be up to 67 weeks. This study will consist of a 1-week Screening Period, a 10-week wash-off period from metformin, if needed, and a 2-week placebo run-in period, a 52-week double-blind treatment period, and a 14-day post-treatment follow-up period. The primary objective of this trial is to assess the hemoglobin A1C (A1C)-lowering efficacy of the addition of ertugliflozin compared to the addition of placebo with an underlying hypothesis that addition of treatment with ertugliflozin provides greater reduction in A1C compared to the addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses of ertugliflozin.

Detailed description:
Participants who meet protocol-defined glycemic rescue criteria will be permitted to have an adjustment in the dose(s) of background antihyperglycemic agent (AHA) therapy or addition of new AHA therapy as directed by their investigator until the participant no longer meets the rescue criteria.

Arms: arm 1: Ertugliflozin, 5 mg, oral, one 5 mg ertugliflozin tablet and one placebo tablet, once daily for 52 weeks arm 2: Ertugliflozin, 15 mg, oral, one 5 mg and one 10 mg tablet, once daily for 52 weeks arm 3: Matching placebo
Interventions: intervention 1: Ertugliflozin 5 mg intervention 2: Placebo 5 mg intervention 3: Ertugliflozin 10 mg intervention 4: Placebo 10 mg
Intervention descriptions: intervention 1: Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks intervention 2: Placebo to ertugliflozin, oral, tablet, 5 mg tablet once daily for 52 weeks intervention 3: Ertugliflozin, oral, tablet, 10 mg tablet once daily for 52 weeks intervention 4: Placebo to ertugliflozin, oral, tablet, 10 mg tablet once daily for 52 weeks

Protocol documents:
Clinical trial NCT02005666
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris DUAC CADILA CLIANTHA
Sponsor: Zydus Lifesciences Limited
Start date: 2013-11-01; Completion date: 2016-09-28
Enrollment: 850 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo Controlled, Three Arm Clinical Study.

The main objective is to evaluate bioequivalence of Test formulation (Clindamycin Phosphate 1.2%/Benzoyl peroxide 5% gel) of Cadila Healthcare with Reference formulation (DUAC® Gel of Stiefel Laboratories)in the ratio of 2:2:1 of Test drug, Reference drug and Placebo respectively.

Total study duration will be for a period of 78 days which includes treatment duration of 77 days.

850 subjects will be enrolled (randomized)as per the inclusion and exclusion criteria mentioned in the protocol.

Detailed description:

Arms: arm 1: Drug:-Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days arm 2: Drug:-DUAC® Gel (of Stiefel Laboratories, USA) Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days arm 3: Drug:-Placebo (Vehicle Gel) Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
Interventions: intervention 1: Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel intervention 2: DUAC® Gel intervention 3: Placebo
Intervention descriptions: intervention 1: Drug:-1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days intervention 2: Drug:-DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days intervention 3: Drug:-Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days

Protocol documents:
Clinical trial NCT02021292
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Keywords: Chronic thromboembolic pulmonary hypertension (CTEPH)
Sponsor: Actelion
Start date: 2014-08-20; Completion date: 2016-09-28
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).

Detailed description:

Arms: arm 1: Macitentan 10 mg, oral tablet, to be taken once daily. arm 2: Matching placebo oral tablet, to be taken once daily.
Interventions: intervention 1: Macitentan intervention 2: Placebo
Intervention descriptions: intervention 1: Macitentan 10 mg, oral tablet, to be taken once daily. intervention 2: Matching placebo oral tablet, to be taken once daily.

Protocol documents:
Clinical trial NCT02290340
Conditions: Respiratory Syncytial Virus
Keywords: Respiratory Syncytial Virus, RSV
Sponsor: MedImmune LLC
Start date: 2015-01-13; Completion date: 2016-09-28
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm infants.

Detailed description:
This Phase 1b/2a study will be a dose-escalation design to begin data collection on PK and safety in children. The population to be enrolled is healthy preterm infants born between 32 weeks 0 days and 34 weeks 6 days gestation who would not receive RSV prophylaxis based on the American Academy of Pediatrics (AAP) or other local guidelines. These subjects will not be receiving palivizumab, allowing for a placebo comparator group to begin collecting data on incidence rates of RSV medically attended lower respiratory illness (MA-LRI) and efficacy. Enrollment is planned at approximately 20 sites in the USA, Chile, and South Africa.

Arms: arm 1: Participants will receive placebo intramuscularly. arm 2: Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly. arm 3: Participants will receive a single dose of MEDI8897 25 mg intramuscularly. arm 4: Participants will receive a single dose of MEDI8897 50 mg intramuscularly.
Interventions: intervention 1: Placebo intervention 2: MEDI8897 10 mg intervention 3: MEDI8897 25 mg intervention 4: MEDI8897 50 mg
Intervention descriptions: intervention 1: Participants will receive placebo intramuscularly. intervention 2: Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly. intervention 3: Participants will receive a single dose of MEDI8897 25 mg intramuscularly. intervention 4: Participants will receive a single dose of MEDI8897 50 mg intramuscularly.

Protocol documents:
Clinical trial NCT02495233
Conditions: Non-Small-Cell Lung Cancer
Keywords: Erlotinib ASP2215 NSCLC Gilteritinib Non-Small-Cell Lung Cancer
Sponsor: Astellas Pharma Global Development, Inc.
Start date: 2015-09-08; Completion date: 2016-09-28
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the Phase 1b part of the study was to evaluate the safety and tolerability of ASP2215 in combination with erlotinib and determine the recommended phase 2 dose (RP2D) of ASP2215. The purpose of the Phase 2 part of the study was to evaluate the objective response rate (ORR) of the RP2D of ASP2215 in combination with erlotinib.

Detailed description:
No patients were enrolled in the Phase 2 part of the study. Phase 2 endpoints were not analyzed.

Arms: arm 1: Gilteritinib was administered in combination with erlotinib orally once daily. arm 2: Gilteritinib was administered in combination with erlotinib orally once daily.
Interventions: intervention 1: Gilteritinib intervention 2: Erlotinib
Intervention descriptions: intervention 1: oral intervention 2: oral

Protocol documents:
Clinical trial NCT02567708
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: GSK2269557 Asthma Pharmacokinetics Safety Adults DISKUS Dry Powder Inhaler Efficacy
Sponsor: GlaxoSmithKline
Start date: 2015-10-01; Completion date: 2016-09-28
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is a multi-centre, randomised, double-blind, placebo-controlled (with rescue medication), two period crossover study in subjects with persistent uncontrolled asthma, currently not treated with an inhaled corticosteroid (ICS) or long acting beta 2 agonist (LABA). This study is the first administration of GSK2269557 to asthmatic subjects, and the aims of the study are to investigate the efficacy, safety, tolerability, and pharmacokinetics of four weeks of treatment with orally inhaled GSK2269557 1000 microgram (mcg) in subjects with persistent uncontrolled asthma. In a sub-study, biological mediators will be measured from induced sputum and blood.

Approximately 50 subjects will be randomised into the study (including approximately 16 subjects in the sputum sub-study). Each subject will complete two treatment periods: subjects will be randomised to receive GSK2269557 1000 mcg in one treatment period, and matching placebo in the other treatment period. Each treatment will be administered once daily for 28 days (+/- 2 days) via the DISKUS™ dry powder inhaler (DPI).

The study will consist of a Screening Visit; a Run-in Period (approximately 2 weeks in duration); two 28-day Treatment Periods (each with 4 clinic visits); a 4-week Washout Period (between the Treatment Periods); and a Follow-up Visit. The total duration of the study for each subject will be approximately 16 weeks. DISKUS is a registered trademark of the GlaxoSmithKline group of companies.

Detailed description:

Arms: arm 1: Each subject will complete two treatment periods: GSK2269557 1000 mcg in one treatment period, and matching placebo in the other treatment period. Each treatment will be administered once daily for 28 days (+/- 2 days) via the DISKUS DPI. The treatment periods will be separated by a washout of at least 4 weeks.
Interventions: intervention 1: GSK2269557 DPI intervention 2: Placebo DPI
Intervention descriptions: intervention 1: GSK2269557 will be supplied as a lactose blend in a DISKUS DPI with a unit dose strength of 500 mcg. 2 inhalations will be taken every morning before breakfast. intervention 2: Placebo will be lactose in a DISKUS DPI. 2 inhalations will be taken every morning before breakfast.

Protocol documents:
Clinical trial NCT02589275
Conditions: Primary Fibromyalgia
Keywords: TNX-102 SL bedtime sublingual 3-month long term safety long term efficacy Fibromyalgia
Sponsor: Tonix Pharmaceuticals, Inc.
Start date: 2015-08-04; Completion date: 2016-09-28
Enrollment: 375 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of Fibromyalgia (FM). Patients recruits into this trial are those who have successfully completed the double-blind studies; TNX-CY-F301 and TNX-CY-F302.

Patients will not be made aware of the therapy they received during the double-blind study.

Detailed description:
The study consist of 4 study visits, including Screening/Baseline Visit 1 (Day 1, which is anticipated to be the same date as Visit 6 in F301 or F302) and visits after 1, 2 and 3 months of treatment (Visits 2-4).

Primary:

The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken daily at bedtime over an additional 3 months in patients with FM who have completed the double-blinded lead-in study

Secondary:

The secondary objective is to evaluate the efficacy of TNX-102 SL tablets taken daily at bedtime to control symptoms of FM

Arms: arm 1: 1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 3 months
Interventions: intervention 1: TNX-102 SL Tablet 2.8 mg
Intervention descriptions: intervention 1: TNX-102 SL 2.8 mg tablet taken daily at bedtime

Protocol documents:
Clinical trial NCT02234362
Conditions: Depression Menopause Vasomotor Disturbance Hot Flashes Sleep
Sponsor: Massachusetts General Hospital
Start date: 2015-06-12; Completion date: 2016-09-29
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The broad goal of this study was to examine the efficacy and tolerability of vortioxetine (flexible dose) for the treatment of major depressive disorder (MDD) in symptomatic women around the menopausal transition. We hypothesized that an eight-week treatment with vortioxetine would promote a significant improvement of depression symptoms and other menopause-related physical symptoms.

Detailed description:
Forty-seven peri- and postmenopausal women were enrolled in this open-label study. This was an 8-week intervention using open-label vortioxetine with flexible dose between 5-20 mg, dependent on participant response and tolerability. In addition to assessment of depressive symptoms, improvement of menopause-related physical and emotional symptoms that occur with MDD, including vasomotor symptoms, cognition, fatigue, anxiety, sleep complaints, and quality of life, were also examined.

Arms: arm 1: flexible-dose vortioxetine of 5-20 mg depending on tolerability
Interventions: intervention 1: vortioxetine
Intervention descriptions: intervention 1: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability.

Protocol documents:
Clinical trial NCT02337764
Conditions: Parkinson's Disease
Sponsor: Takeda
Start date: 2015-02-03; Completion date: 2016-09-29
Enrollment: 222 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate long-term safety of TVP-1012 (1 mg/day) with levodopa in Japanese participants with Parkinson's disease.

Detailed description:
This is a multicenter, open-label, long-term, phase 3 study to evaluate the safety and efficacy of long-term administration of TVP-1012 at 1 mg with levodopa in Japanese participants with Parkinson's disease.

The study period consisted of a 2-week run-in period and a subsequent 52-week treatment period. Participants fulfilling the inclusion criteria and did not meet any of the exclusion criteria at the start of the run-in period (Week -2) and also at the end of the run-in period (Week 0) were enrolled in the study, and received 1 mg of TVP-1012 once daily for 52 weeks, in an unblinded manner, from the day after Week 0.

Arms: arm 1: TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet for 52 weeks as treatment period after 2 weeks of run-in period.
Interventions: intervention 1: TVP-1012 1mg
Intervention descriptions: intervention 1: TVP-1012 1mg Tablets

Protocol documents: