ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01687283
Conditions: Asthma
Keywords: fluticasone propionate inhalation solution budesonide suspension for inhalation efficacy severe persistent asthma pharmacokinetics safety
Sponsor: GlaxoSmithKline
Start date: 2012-09-27; Completion date: 2013-11-07
Enrollment: 316 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicentre, randomized, single-blind, active-controlled, parallel-group phase III local registration study for a treatment period of 12 weeks. This study aims to assess the effectiveness and safety of fluticasone propionate 1mg via nebulizer BID in treatment of Chinese adult and adolescent patients with severe persistent asthma for a treatment period of 12 weeks versus budesonide 2mg via nebulizer BID. The steady-state plasma pharmacokinetics of fluticasone propionate inhalation solution will also be assessed.

Detailed description:
Male or female subjects between 17 to 70 (inclusive) years of age with severe persistent asthma meeting the inclusion criteria and having completed the screening period of 2 weeks will, in a proportion of 1:1, randomly receive fluticasone propionate 1mg via nebulizer BID or budesonide 2mg via nebulizer BID for a treatment period of 12 weeks. The clinic visit will be arranged at 2 weeks, 4 weeks, 8 weeks and 12 weeks during study treatment. If the subjects meet the criteria of pre-defined asthma control at treatment 4 weeks or 8 weeks, they will have one chance to be treated with the half dose of study drug. 2 weeks after completion of study treatment or after early withdrawal from study, the follow-up visit will be performed to assess the post-treatment adverse events. The primary endpoint is the mean change from baseline in morning peak expiratory flow (PEF) over the 12 week treatment period. Safety assessments include adverse events, vital signs, oral and oropharyngeal candidiasis, hematological, biochemical tests), 24-hour urinary cortisol and 12-lead ECG. The steady-state plasma pharmacokinetics of fluticasone propionate inhalation solution will also be assessed.

Arms: arm 1: 1 mg BID inhalation via nebulizer arm 2: 2 mg BID inhalation via nebulizer
Interventions: intervention 1: fluticasone propionate inhalation solution intervention 2: budesonide suspension
Intervention descriptions: intervention 1: 1 mg BID inhalation for 12 weeks with one possible chance to change to 0.5 mg BID intervention 2: 2 mg BID inhalation for 12 weeks with one possible chance to change to 1 mg BID

Protocol documents:
Clinical trial NCT01934231
Conditions: Sinusitis, Acute
Keywords: Acute bacterial rhinosinusitis Amoxicilin Infection Potassium clavulanate
Sponsor: GlaxoSmithKline
Start date: 2013-08-30; Completion date: 2013-11-07
Enrollment: 27 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Acute Bacterial Rhinosinusitis (ABRS) is a respiratory inflammation commonly seen in clinical practice, which has with respiratory symptoms including nasal congestion, rhinorrhoea, postnasal discharge and cough and is associated with headache, cheek pain, facial pressure and other conditions. The principal bacterial pathogens in causing ABRS include Streptococcus pneumoniae, Haemophilus influenzae and Moraxella (Branhamella) catarrhalis. These three bacteria account for approximately 90% of ABRS in children less than or equal to 5 years of age. Combination of Potassium Clavulanate (CVA) and Amoxicillin (AMPC) produces higher antibiotic activity against beta-lactamase-producing bacteria. The present study is designed to assess the clinical efficacy, bacteriological efficacy and safety of CVA/AMPC (1:14) administered in children aged from 3 months to less than 15 years with ABRS. It is an open-label study consisting of a 7-day treatment phase and a post-treatment follow-up phase for 7 to 14 days.

Detailed description:

Arms: arm 1: Each participant will take Potassium Clavulanate (CVA)/ Amoxicillin (AMPC) corresponding 6.4/90 mg/kg/day in two divided doses (every 12 hours) just before lactation or meal for 7 days depending on his/her body weight at the start of treatment (Day 1). The actual daily dose depends on the body weight of the participant.
Interventions: intervention 1: Amoxicillin-Potassium Clavulanate Combination
Intervention descriptions: intervention 1: The drug is available in two sachets (CVA/AMPC Dry Syrup 0.505 g and CVA/AMPC Dry Syrup 1.01 g). CVA/AMPC Dry Syrup 1.01 g sachet contains 42.9 mg of Potassium Clavulanate and 600 mg of Amoxicillin Hydrate. It is a white to yellowish white powder and has strawberry flavor and it is white to yellowish white suspension when it is suspended before use.

Protocol documents:
Clinical trial NCT00615784
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia AML Bexarotene
Sponsor: Abramson Cancer Center at Penn Medicine
Start date: 2010-05-25; Completion date: 2013-11-08
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant to standard chemotherapy or are otherwise not eligible for conventional chemotherapy. Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects within normal and malignant cells that affect cell growth and cell death.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Bexarotene
Intervention descriptions: intervention 1: Bexarotene given orally at a dose of 300mg/m2 until disease progression or unacceptable toxicities experienced by patient

Protocol documents:
Clinical trial NCT01515865
Conditions: Symptomatic Orthostatic Hypotension
Sponsor: Shire
Start date: 2012-05-23; Completion date: 2013-11-11
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To study the effect of midodrine against the symptoms of orthostatic hypotension

Detailed description:
The efficacy of midodrine will be assessed in those subjects who have severe symptoms of orthostatic hypotension when not taking midodrine and are controlled when taking midodrine. The study will involve approximately 9 overnight stays.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Midodrine HCl intervention 2: Placebo
Intervention descriptions: intervention 1: dose at subject's current dose level intervention 2: single dose of matching placebo

Protocol documents:
Clinical trial NCT00424047
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma Celgene Revlimid CC-5013
Sponsor: Celgene
Start date: 2003-01-01; Completion date: 2013-11-12
Enrollment: 351 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refractory multiple myeloma."

Detailed description:

Arms: arm 1: Arm A: Oral CC-5013 is initiated on Day 1 of Cycle 1 at a dose of 25 mg daily for 21 days every 28 days. Therefore, the subject will take a placebo identical in appearance to the CC-5013 capsule for week 4 of every 28 days. Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral CC-5013 placebo capsules will be administered for 28 days of every cycle. arm 2: Arm B: Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.
Interventions: intervention 1: CC-5013 plus dexamethasone intervention 2: Dexamethasone plus Placebo
Intervention descriptions: intervention 1: 25 mg daily for 21 days every 28 days. intervention 2: Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.

Protocol documents:
Clinical trial NCT01885000
Conditions: Rosacea Erythema
Sponsor: Galderma R&D
Start date: 2013-07-01; Completion date: 2013-11-14
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the patient-reported outcomes (feedbacks of patients)of a new drug for the treatment of erythema of rosacea (central facial redness). The feedback of patients receiving the active drug will be compared to the feedback of patients receiving the placebo.

Detailed description:

Arms: arm 1: Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. arm 2: Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
Interventions: intervention 1: Brimonidine tartrate was applied cutaneously once daily for 8 days. intervention 2: Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01534351
Conditions: Benign Prostatic Hyperplasia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-08-01; Completion date: 2013-11-18
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to compare safety and efficacy of monotherapy finasteride to combination therapy (finasteride and tamsulosin) in Asian men with benign prostatic hyperplasia (BPH) who are at least 50 years of age or older. The primary hypotheses are that concomitantly-dosed finasteride 5 mg and tamsulosin 0.2 mg will be superior with respect to BPH symptoms compared to monotherapy with finasteride 5 mg as measured by change from baseline on the International Prostate Symptoms Score (IPSS) and will be superior with respect to prostate volume reduction compared to montherapy with tamsulosin 0.2 mg as measured by percent change from baseline in prostate volume.

Detailed description:

Arms: arm 1: Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together. arm 2: Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together. arm 3: Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
Interventions: intervention 1: Finasteride intervention 2: Tamsulosin intervention 3: Finasteride-matching placebo intervention 4: Tamsulosin-matching placebo
Intervention descriptions: intervention 1: Finasteride 5 mg oral tablet taken once daily. intervention 2: Tamsulosin 0.2 mg oral capsule taken once daily. intervention 3: Matching placebo to finasteride 5 mg oral tablet taken once daily. intervention 4: Matching placebo to tamsulosin 0.2 mg oral capsule taken once daily.

Protocol documents:
Clinical trial NCT01763905
Conditions: Hyperlipidemia
Keywords: High Cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
Sponsor: Amgen
Start date: 2013-01-24; Completion date: 2013-11-19
Enrollment: 307 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).

Detailed description:

Arms: arm 1: Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. arm 2: Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. arm 3: Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. arm 4: Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
Interventions: intervention 1: Evolocumab intervention 2: Placebo to Evolocumab intervention 3: Ezetimibe intervention 4: Placebo to Ezetimibe
Intervention descriptions: intervention 1: Subcutaneous injection intervention 2: Subcutaneous injection intervention 3: Tablet for oral administration intervention 4: Tablet for oral administration

Protocol documents:
Clinical trial NCT01816139
Conditions: Vulvovaginal Atrophy
Keywords: vaginal dryness vaginal atrophy estrogen
Sponsor: Warner Chilcott
Start date: 2013-01-31; Completion date: 2013-11-19
Enrollment: 576 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as measured by self-assessment, vaginal pH and vaginal smear.

Detailed description:

Arms: arm 1: Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks. arm 2: WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
Interventions: intervention 1: Vehicle intervention 2: WC3011 Estradiol Vaginal Cream
Intervention descriptions: intervention 1: Vehicle Cream applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks intervention 2: WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks

Protocol documents:
Clinical trial NCT01845649
Conditions: Vulvovaginal Atrophy
Keywords: Vulvovaginal Atrophy Dyspareunia Postmenopausal
Sponsor: Warner Chilcott
Start date: 2013-04-12; Completion date: 2013-11-20
Enrollment: 550 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle.

Detailed description:

Arms: arm 1: Vehicle applied to the vagina daily for 14 days followed by dosing 3 times per week for 10 weeks. arm 2: WC3011 Estradiol vaginal cream applied daily for 14 days followed by dosing 3 times per week for 10 weeks.
Interventions: intervention 1: WC3011 Estradiol Vaginal Cream intervention 2: Vehicle
Intervention descriptions: intervention 1: Daily for 14 days followed by 3 times per week for 10 weeks intervention 2: Daily for 14 days followed by 3 times per week for 10 weeks

Protocol documents:
Clinical trial NCT01554579
Conditions: Osteoarthritis of the Knee
Sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2012-03-29; Completion date: 2013-11-21
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy of a single dose level of gefapixant (AF-219/MK-7264) in subjects with moderate to severe pain associated with osteoarthritis (OA) of the knee compared with placebo after 4 weeks of treatment.

The study will also assess the safety and tolerability, changes in physical function, stiffness, treatment response and health outcomes.

Detailed description:
Subjects who satisfy entry criteria at Screening will enter the Washout Phase, discontinuing their current nonsteroidal anti-inflammatory drug (NSAID) therapy.

Up to 220 subjects who fulfill flare (and other entry) criteria will be randomized to gefapixant or placebo.

Subjects will complete Treatment Visits 1, 2, 3, and 4 weeks after starting study drug. At each Treatment Visit, subjects will undergo efficacy assessments and safety procedures. During the Washout and Treatment Phases subjects will complete the 'average pain' Numeric Pain Rating Scale (NPRS) and count of rescue medication used for the preceding 24 hours.

Subjects will return 2 weeks after their last Treatment Visit (for a Follow-Up Visit).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Gefapixant intervention 2: Sugar Pill
Intervention descriptions: intervention 1: BID intervention 2: Placebo

Protocol documents:
Clinical trial NCT01929863
Conditions: Diabetes Mellitus, Type 2
Keywords: Metformin Diabetes
Sponsor: GlaxoSmithKline
Start date: 2013-08-01; Completion date: 2013-11-21
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Metformin may have complex interactions in the gut and is generally first line therapy for type 2 diabetes mellitus (T2DM). It is important to understand whether there are significant pharmacokinetic or pharmacodynamic interactions when GSK2330672 is co-administered with metformin in subjects with T2DM. The purpose of this study is to investigate the safety and tolerability of GSK2330672 administered for 7 days to subjects with T2DM taking metformin. This will be a two-period crossover study; subjects will receive either GSK2330672 or placebo for 7 days in each period separated by a washout period of 13 to 15 days. All subjects will receive metformin throughout the study

Detailed description:

Arms: arm 1: Subjects will receive metformin 850 mg BID for 7 days, GSK2330672 45 mg BID on Days 1 and 2 and GSK2330672 90 mg BID on Days 3 to 7 in treatment period 1. Subjects will receive metformin 850 mg BID for 7 days, placebo (matching 45 mg GSK2330672) BID on Days 1 and 2 and placebo (matching 90 mg GSK2330672) BID on Days 3 to 7 in treatment period 2. Treatment periods will be separated by a washout period of 13 to 15 days in which subjects will continue metformin 850 mg BID only arm 2: Subjects will receive metformin 850 mg BID for 7 days, placebo (matching 45 mg GSK2330672) BID on Days 1 and 2 and placebo (matching 90 mg GSK2330672) BID on Days 3 to 7 in treatment period 1. Subjects will receive metformin 850 mg BID for 7 days, GSK2330672 45 mg BID on Days 1 and 2 and GSK2330672 90 mg BID on Days 3 to 7 in treatment period 2. Treatment periods will be separated by a washout period of 13 to 15 days in which subjects will continue metformin 850 mg BID only
Interventions: intervention 1: GSK2330672 intervention 2: Placebo intervention 3: Metformin
Intervention descriptions: intervention 1: GSK2330672 will be supplied as oral solution, and will be administered BID \[45 mg (2 days repeat dose) and 90 mg (5 days repeat dose) in each period\] intervention 2: GSK2330672 matching placebo will be supplied as oral solution, and will be administered BID (7 days of dosing in each period) intervention 3: Metformin 850 mg will be administered BID from Run-in period till Day 7 of period 2

Protocol documents:
Clinical trial NCT01806623
Conditions: Vulvovaginal Candidiasis
Sponsor: Pfizer
Start date: 2013-03-05; Completion date: 2013-11-22
Enrollment: 157 participants; Allocation: NA; Intervention model: PARALLEL

Brief summary:
As for the indication of vulvovaginal candidiasis, a single oral administration of fluconazole 150 mg has been approved and is recommended by guidelines overseas. However in Japan oral therapy with antifungal triazole such as Fluconazole has not been approved, and topical therapies such as vaginal tablets, pessary and cream are used clinically. The purpose of this trial is to confirm the efficacy and safety of single oral administration of fluconazole 150 mg for the treatment of vulvovaginal candidiasis in Japanese patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Fluconazole
Intervention descriptions: intervention 1: Single oral dose of 150mg Fluconazole

Protocol documents:
Clinical trial NCT01211483
Conditions: NSCLC (Advanced Non-small Cell Lung Cancer)
Keywords: Lung cancer
Sponsor: Daiichi Sankyo
Start date: 2010-09-01; Completion date: 2013-11-23
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 1b/2 study. In Phase 1b, subjects will know the treatment they are receiving. Subjects will receive Erlotinib + U3-1287. The Phase 1b portion will determine if adding U3-1287 to Erlotinib will be safe in subjects with advanced non-small cell lung cancer who fail prior treatment. In the Phase 2 portion, subjects will be blinded to the treatments they are receiving. Subjects will receive either Erlotinib alone or Erlotinib + U3-1287.

The Phase 2 portion will determine if adding U3-1287 to Erlotinib will be safe and improve survival in subjects with advanced non-small cell lung cancer who failed the first treatment.

Detailed description:

Arms: arm 1: U3-1287 (high dose) intravenously (IV) every three weeks (Q3W) + Erlotinib 150 mg/day orally (PO) until cancer gets worse, side effects become unacceptable or participant withdraws consent arm 2: U3-1287 (low dose) IV Q3W + Erlotinib 150 mg/day PO until cancer gets worse, side effects become unacceptable or participant withdraws consent arm 3: Placebo matching U3-1287 IV Q3W + Erlotinib150 mg/day PO until cancer gets worse, side effects become unacceptable or participant withdraws consent
Interventions: intervention 1: U3-1287 intervention 2: Erlotinib intervention 3: Placebo
Intervention descriptions: intervention 1: Liquid 70 mg/mL for IV infusion at high dose or low dose intervention 2: Tablet 150 mg for oral administration intervention 3: Placebo liquid matching U3-1287 for IV infusion

Protocol documents:
Clinical trial NCT00622336
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma Revlimid
Sponsor: Celgene
Start date: 2003-04-01; Completion date: 2013-11-25
Enrollment: 330 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study evaluated the safety of Lenalidomide monotherapy in participants with advanced multiple myeloma who had discontinued treatment with combination thalidomide plus high-dose dexamethasone or high-dose dexamethasone alone in studies Thal-MM-003, CC-5013-MM-009 and CC-5013-MM-010 due to the development of documented disease progression or the inability to tolerate the lowest dosing regimen per previous protocol of thalidomide and/or high-dose dexamethasone without grade 3 or 4 toxicity.

Detailed description:

Arms: arm 1: Oral 25mg daily on Days 1-21 every 28 days
Interventions: intervention 1: CC-5013 intervention 2: Lenalidomide
Intervention descriptions: intervention 1: Oral 25mg daily on Days 1-21 every 28 days. intervention 2: Oral Lenalidomide 25mg daily on Days 1-21 every 28 days.

Protocol documents: