ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02279641
Conditions: Gout
Sponsor: Ardea Biosciences, Inc.
Start date: 2014-11-01; Completion date: 2015-09-11
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 1b, randomized, open-label, drug-drug interaction study in adult male subjects with gout. It is designed to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of RDEA3170 or allopurinol alone and in combination in the fed state.

Detailed description:

Arms: arm 1: RDEA3170 qd (once daily), RDEA3170 + allopurinol qd, allopurinol qd arm 2: allopurinol qd, RDEA3170 + allopurinol qd, RDEA3170 qd
Interventions: intervention 1: RDEA3170 10 mg intervention 2: allopurinol 300 mg
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02186652
Conditions: Gastroesophageal Reflux Disease
Keywords: obese children adolescents GERD pharmacokinetic
Sponsor: Phillip Brian Smith
Start date: 2014-06-04; Completion date: 2015-09-13
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Multicenter, comparative single-dose pharmacokinetic (PK) study

Detailed description:
Evaluate the pharmacokinetics of pantoprazole in obese children and adolescents with gastroesophageal reflux disease (GERD) following administration of an oral dose of pantoprazole.

Arms: arm 1: None
Interventions: intervention 1: Pantoprazole
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00718549
Conditions: Lymphocytic Leukemia, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2009-07-21; Completion date: 2015-09-14
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the effect of maintenance treatment with rituximab in comparison with observation period (no treatment), in participants with progressive B-cell CLL who have had previous first-line induction treatment with rituximab, cladribine and cyclophosphamide (RCC regimen). After 6 months of RCC induction therapy, participants will be randomized either to receive maintenance treatment with rituximab or to receive no treatment (observation only) for 96 weeks. Participants completing maintenance/observation period will be followed-up for approximately 3 years.

Detailed description:

Arms: arm 1: Participants will receive rituximab at a dose of 375 milligrams per meter squared (mg/m\^2) as intravenous (IV) infusion on Day 1, cladribine at a dose of 0.12 milligrams per kilogram per day (mg/kg/day) as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m\^2/day as IV infusion over 15-30 minutes on Days 2-4 in Cycle 1. Then, rituximab at a dose of 500 mg/m\^2 as IV infusion on Day 1, cladribine at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m\^2/day as IV infusion over 15-30 minutes on Days 2-4 will be administered in Cycles 2-6. Each cycle will be of 28 days in duration. arm 2: Participants with PR or CR after induction phase who will be randomized to maintenance arm will receive rituximab treatment for 8 cycles. Twelve weeks after the last induction cycle, participants will receive rituximab at a dose of 375 mg/m\^2 as IV infusion on Day 1 of each 12-week cycle until disease progression (up to approximately 96 weeks). arm 3: Participants with PR or CR after induction phase who will be randomized to observation arm will not receive any intervention. Participants will be assessed every 4-weeks for the first 12 weeks and every 12-weeks afterwards up to 96 weeks.
Interventions: intervention 1: Cladribine intervention 2: Cyclophosphamide intervention 3: Rituximab
Intervention descriptions: intervention 1: Cladribine will be adminiatered at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4 of each 28-day cycle during induction phase. intervention 2: Cyclophosphamide will be administred at a dose of 250 mg/m\^2/day as IV infusion over 15-30 minutes on Days 2-4 of each 28-day cycle during induction phase. intervention 3: Rituximab will be administered at a dose of 375 mg/m\^2 as IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 as IV infusion on Day 1 of Cycles 2-6 during induction phase. Rituximab will be administered at a dose of 375 mg/m\^2 as IV infusion on Day 1 of each 12-week cycle during maintenance phase.

Protocol documents:
Clinical trial NCT01360554
Conditions: Non-Small Cell Lung Cancer
Keywords: comparative study of PF-00299804 and Erlotinib Double-Blind Phase 3 trial of TKI
Sponsor: Pfizer
Start date: 2011-06-16; Completion date: 2015-09-14
Enrollment: 878 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.

Detailed description:

Arms: arm 1: Blinded active PF-00299804 + blinded placebo comparator (erlotinib) arm 2: Blinded active comparator (erlotinib) + blinded placebo PF-00299804
Interventions: intervention 1: Dacomitinib (PF-00299804) intervention 2: Active Comparator (erlotinib) intervention 3: Placebo erlotinib intervention 4: Placebo PF00299804
Intervention descriptions: intervention 1: Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing intervention 2: Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing intervention 3: placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing. intervention 4: placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing

Protocol documents:
Clinical trial NCT01814748
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin Hypoglycemic Agents Pharmacologic Actions Therapeutic Uses
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-05-03; Completion date: 2015-09-14
Enrollment: 203 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the safety and efficacy of once-weekly omarigliptin in participants 18 to \<45 years of age with Type 2 diabetes mellitus and inadequate glycemic control. The study hypothesis is that treatment with omarigliptin compared with placebo provides greater reduction in hemoglobin A1c (A1C) in participants after 24 weeks.

Detailed description:

Arms: arm 1: Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited. arm 2: Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
Interventions: intervention 1: Omarigliptin intervention 2: Placebo to omarigliptin intervention 3: Metformin
Intervention descriptions: intervention 1: Omarigliptin 25 mg capsule administered orally once weekly intervention 2: Matching placebo to omarigliptin 25 mg capsule administered orally once weekly intervention 3: Open-label metformin (dosed daily according to the country-specific product label) was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.

Protocol documents:
Clinical trial NCT01500694
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor: Shire
Start date: 2012-03-20; Completion date: 2015-09-15
Enrollment: 215 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
For subjects in Europe that have already participated in either Study SPD503-315 or SPD503-316. This is an extension study that will allow participants access to Extended-release Guanfacine Hydrochloride (HCl) for up to 2 years. This study will help the sponsor evaluate long-term safety and tolerability of Extended-release Guanfacine HCl (SPD503).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Extended-release Guanfacine HCl (Intuniv, SPD503)
Intervention descriptions: intervention 1: Subjects will be dosed orally once-daily in the AM at 1, 2, 3, 4, 5, 6, or 7 mg according to subjects weight and age

Protocol documents:
Clinical trial NCT01957579
Conditions: Blood Cancer Advanced B Cell Malignancies
Keywords: Phase I advanced B cell malignancies dose escalation CD19 Japanese
Sponsor: AstraZeneca
Start date: 2011-05-25; Completion date: 2015-09-15
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the safety and tolerability of MEDI-551 in Japanese patients with relapsed or refractory advanced B-cell malignancies.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: MEDI-551
Intervention descriptions: intervention 1: MEDI-551 will be administered by intravenous infusion at dose of 2, 4 or 8 mg/kg once per week on Days 1 and 8 in the first cycle and then once every 28 days at the start of each subsequent cycle

Protocol documents:
Clinical trial NCT02210780
Conditions: Atopic Dermatitis
Sponsor: Regeneron Pharmaceuticals
Start date: 2014-08-05; Completion date: 2015-09-15
Enrollment: 194 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a 32-week, randomized, double-blind, placebo-controlled, parallel-group study assessing immunization responses to vaccination in adults with moderate to severe atopic dermatitis who are treated with subcutaneous dupilumab.

Detailed description:

Arms: arm 1: Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. arm 2: Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
Interventions: intervention 1: Dupilumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered via subcutaneous injection. intervention 2: An inactive substance containing no medicine administered via subcutaneous injection.

Protocol documents:
Clinical trial NCT01049945
Conditions: Refractory Multiple Myeloma
Sponsor: Mayo Clinic
Start date: 2010-02-01; Completion date: 2015-09-16
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Giving bendamustine hydrochloride together with lenalidomide and dexamethasone may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of bendamustine hydrochloride and lenalidomide when given together with dexamethasone and to see how well they work in treating patients with relapsed multiple myeloma.

Detailed description:
PRIMARY OBJECTIVES: I. To determine the Maximum Tolerated Dose (MTD) of bendamustine and lenalidomide in combination with dexamethasone in subjects with Multiple Myeloma (MM) in first or second relapse. (Phase I) II. To evaluate the confirmed response rate of bendamustine in combination with lenalidomide and dexamethasone in subjects with MM in first or second relapse. (Phase II) SECONDARY OBJECTIVES: I. To evaluate the safety of bendamustine in combination with lenalidomide and dexamethasone. (Phase I and II) II. To evaluate time-to-tumor-progression, progression-free survival, duration of response, and overall survival. (Phase II) OUTLINE: This is a phase I dose escalation study of bendamustine hydrochloride and lenalidomide followed by a phase II study. Patients receive dexamethasone orally or IV on days 1, 8, 15, and 22; bendamustine hydrochloride IV over 30 minutes on days 1 and 2; and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least stable disease after 6 courses may continue to receive lenalidomide and dexamethasone as above in the absence of disease progression or unacceptable toxicity. Dexamethasone may be discontinued after 12 courses of therapy at the treating investigator's discretion. After completion of study treatment, patients are followed at 4 weeks and then periodically for up to 2 years.

Arms: arm 1: Patients receive dexamethasone orally or IV on days 1, 8, 15, and 22; bendamustine hydrochloride IV over 30 minutes on days 1 and 2; and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: bendamustine hydrochloride intervention 2: lenalidomide intervention 3: dexamethasone
Intervention descriptions: intervention 1: Given IV intervention 2: Given orally intervention 3: Given orally or IV

Protocol documents:
Clinical trial NCT01951638
Conditions: Heart Failure
Keywords: Worsening Heart Failure Heart Failure with Preserved Ejection Fraction
Sponsor: Bayer
Start date: 2013-11-06; Completion date: 2015-09-16
Enrollment: 477 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)

Detailed description:

Arms: arm 1: 2.5 mg orally once daily for 2 weeks, up-titration to 5 mg orally once daily for 2 weeks, up-titration to 10 mg orally once daily for 8 weeks arm 2: 2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration) arm 3: 2.5 mg orally once daily for 12 weeks (with sham titrations) arm 4: 1.25 mg orally once daily for 12 weeks (with sham titrations) arm 5: Orally once daily for 12 weeks (with sham titrations)
Interventions: intervention 1: Vericiguat (BAY1021189) (1.25 mg) intervention 2: Vericiguat (BAY1021189) (5 mg) intervention 3: Placebo
Intervention descriptions: intervention 1: 1.25 mg BAY1021189 tablets intervention 2: 5 mg BAY1021189 tablets intervention 3: None

Protocol documents:
Clinical trial NCT00712881
Conditions: Breast Cancer
Sponsor: Cephalon, Inc.
Start date: 2008-10-13; Completion date: 2015-09-17
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of treatment with MYOCET® (doxorubicin hydrochloride) in combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus trastuzumab, 4 cycles, in women with stage II or III breast cancer whose tumour overexpresses the human epidermal growth factor receptor 2 (HER2) gene.

Detailed description:

Arms: arm 1: Participants will receive MCH (liposomal doxorubicin hydrochloride \[60 milligrams {mg}/square meter {m\^2}\], cyclophosphamide (600 mg/m\^2), and trastuzumab (8 or 6 mg/kilogram {kg}), administered as intravenous (IV) infusion on Day 1 of each of 4 consecutive 21-day cycles. For the first cycle, the loading dose of trastuzumab will be 8 mg/kg; 6 mg/kg will be used for the remaining cycles. After 4 cycles of MCH, the treatment will be changed to 4 consecutive 21-day cycles of TH (docetaxel \[100 mg/m\^2\] and trastuzumab \[6 mg/kg\]). arm 2: Participants will receive AC (free doxorubicin hydrochloride \[60 mg/m\^2\] and cyclophosphamide \[600 mg/m\^2\]), administered as IV infusion on Day 1 of each of 4 consecutive 21-day cycles. After 4 cycles of AC, the treatment will be changed to 4 consecutive 21-day cycles of TH (docetaxel \[100 mg/m\^2\] and trastuzumab \[8 or 6 mg/kg\]). For the first cycle, the loading dose of trastuzumab will be 8 mg/kg; 6 mg/kg will be used for the remaining cycles.
Interventions: intervention 1: Liposomal doxorubicin hydrochloride intervention 2: Cyclophosphamide intervention 3: Trastuzumab intervention 4: Free doxorubicin hydrochloride intervention 5: Docetaxel
Intervention descriptions: intervention 1: Liposomal doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description. intervention 2: Cyclophosphamide will be administered per dose and schedule specified in the arm description. intervention 3: Trastuzumab will be administered per dose and schedule specified in the arm description. intervention 4: Free doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description. intervention 5: Docetaxel will be administered per dose and schedule specified in the arm description.

Protocol documents:
Clinical trial NCT02616601
Conditions: Actinic Keratosis
Sponsor: Actavis Inc.
Start date: 2015-02-27; Completion date: 2015-09-17
Enrollment: 422 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the efficacy and safety of a generic formulation of fluorouracil 0.5% cream against the brand product (Carac) in participants with actinic keratoses.

Detailed description:
This is a multicenter, double-blind, vehicle-controlled, parallel group comparison study of a generic fluorouracil cream, 0.5% and Carac (fluorouracil) Cream, 0.5% in participants with actinic keratoses on the full face or balding scalp.

Arms: arm 1: Participants are to apply up to 1 gram of generic fluorouracil 0.5% topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream is no longer visible. Participants will be instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug should be left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should be continued for the full treatment course even if the actinic keratoses lesions appear to be gone. arm 2: Participants are to apply up to 1 gram of Carac (fluorouracil) 0.5% topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream is no longer visible. Participants will be instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug should be left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should be continued for the full treatment course even if the actinic keratoses lesions appear to be gone. arm 3: Participants are to apply up to 1 gram of vehicle topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream is no longer visible. Participants will be instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug should be left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should be continued for the full treatment course even if the actinic keratoses lesions appear to be gone.
Interventions: intervention 1: Generic Fluorouracil Cream intervention 2: Carac® (Fluorouracil) Cream intervention 3: Vehicle Cream
Intervention descriptions: intervention 1: Topical cream, generic formulation of the brand product. intervention 2: Topical cream, brand product. intervention 3: Topical cream, placebo. Has no active ingredient.

Protocol documents:
Clinical trial NCT01307631
Conditions: Endometrial Adenocarcinoma Endometrial Adenosquamous Carcinoma Endometrial Clear Cell Adenocarcinoma Endometrial Serous Adenocarcinoma Recurrent Uterine Corpus Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2011-03-01; Completion date: 2015-09-18
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with recurrent or advanced endometrial cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the activity of MK-2206 (Akt inhibitor MK2206) in patients with recurrent or persistent endometrial cancer classified by phosphoinositide-3-kinase catalytic alpha (PIK3CA) mutation. Activity will be ascertained by the proportion of patients who survive progression-free for at least 6 months after initiating therapy or who have objective tumor response.

II. To evaluate the efficacy of MK2206 in patients with serous tumors using a composite endpoint of complete and partial response by Response Evaluation Criteria In Solid Tumors (RECIST) and progression-free interval of 6 months or longer.

SECONDARY OBJECTIVES:

I. To determine the duration of progression-free survival and overall survival. II. To determine the nature and degree of toxicity of MK-2206 as assessed by version 4 of the National Cancer Institute (NCI) Common Terminology Criteria For Adverse Events (CTCAE) in these cohorts of patients.

III. To explore the associations between select biomarkers and response to MK-2206 such as progression-free survival, objective tumor response, and overall survival as well as patient characteristics such as histological cell type.

IV. To explore the development of feed-back loop activation (post-treatment biopsy biomarker analysis) and target inhibition using MK-2206 via analysis of pre-treatment and post-treatment biopsies in select patients enrolled in the trial.

V. To determine the duration of progression-free and overall survival, following initiation of therapy with MK-2206.

VI. To determine the toxicities of MK-2206, as assessed with the revised NCI CTCAE version 4.

VII. To explore the association between select biomarkers and response to MK-2206 such as progression-free survival, objective tumor response.

OUTLINE:

Patients receive Akt inhibitor MK2206 orally (PO) once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 3 years.

Arms: arm 1: Patients receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Akt Inhibitor MK2206 intervention 2: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents: