ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00749879
Conditions: Pharmacokinetics
Keywords: PK Pharmacokinetics
Sponsor: Repros Therapeutics Inc.
Start date: 2008-08-11; Completion date: 2008-10-23
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed and fasting states.

Detailed description:
This study is intended to evaluate the pharmacokinetic properties of two doses (25 mg and 50 mg) of Proellex® formulated with microcrystalline cellulose (MCC) from 2 different suppliers in the fed and fasting states.

Arms: arm 1: 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose

Fed State arm 2: 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose

Fasting State arm 3: 2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose

Fed State arm 4: 2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose

Fasting State arm 5: 2, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose

Fasting State
Interventions: intervention 1: Proellex
Intervention descriptions: intervention 1: 25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting

Protocol documents:
Clinical trial NCT00530062
Conditions: Asthma
Keywords: Asthma and Poor Coordinators of Asthma Inhalers
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2007-07-25; Completion date: 2008-10-24
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a research study designed to compare the single-dose efficacy of albuterol-hydrofluoroalkane-breath-actuated inhaler (HFA-BAI) and albuterol-HFA-metered-dose inhaler (MDI) in asthmatics with poor inhaler coordinating abilities.

Detailed description:

Arms: arm 1: Participants will receive single actuation of albuterol 90 micrograms (mcg), administered using BAI in treatment period 1 or 2. arm 2: Participants will receive single actuation of albuterol 90 mcg, administered using MDI in treatment period 1 or 2.
Interventions: intervention 1: Albuterol-HFA-MDI intervention 2: Albuterol-HFA-BAI
Intervention descriptions: intervention 1: Inhalation Aerosols, 90 mcg, 1 dose per treatment period intervention 2: Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.

Protocol documents:
Clinical trial NCT00687440
Conditions: Breast Neoplasm
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-07-15; Completion date: 2008-10-24
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate, in a first stage, the safety (incidence of cardiac toxicity) of Caelyx in combination with Trastuzumab and Docetaxel; and in a second stage, the tumor response rate of this regimen. This study will be conducted in approximately 30 centers. A total of approximately 70 to 95 subjects will be enrolled.

Detailed description:

Arms: arm 1: Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.

Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab.
Interventions: intervention 1: Pegylated Liposomal Doxorubicin intervention 2: Docetaxel intervention 3: Trastuzumab
Intervention descriptions: intervention 1: Stage 1: 25 subjects will be treated with Caelyx IV 30 mg/m\^2 on day 1, every 3 weeks

Stage 2: 45 new patients will be treated at the recommended dose level (defined in the first step) on day 1, every 3 weeks. intervention 2: Stage 1 and Stage 2: Docetaxel 60 mg/m2 IV as 1-hour infusion, on day 1, every 3 weeks. intervention 3: Stage 1 and Stage 2: 4 mg/kg IV 90-minute infusion loading dose. Then 2 mg/kg IV weekly during 6 cycles (18 weeks).

Protocol documents:
Clinical trial NCT00725075
Conditions: Schizophrenia
Keywords: Negative symptoms Glycine Uptake inhibitor Add-on treatment Second Generation Antipsychotic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-04-10; Completion date: 2008-10-24
Enrollment: 215 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether MK-8435 (Org 25935) is more effective than placebo in improving negative symptoms in participants with schizophrenia who are concurrently treated with a stable dose of a second generation antipsychotic.

Detailed description:
The primary features of schizophrenia are characterized by positive (irrational thoughts and/or behavior) and negative symptoms. Negative symptoms are the gross absence of normal behavior and emotions, and usually include a general lack of engagement, social withdrawal, and loss of goal-directed behavior.

Negative symptoms may strongly affect daytime activities and quality of life. The effects of currently available antipsychotics on negative symptoms are not satisfactory and leave much room for improvement. MK-8435 (Org 25935) is an investigational drug that may help to correct the above characteristics of schizophrenia by facilitating the messenger function of an amino acid in the brain, called glutamate. Preliminary data suggest that lowered glutamate levels in schizophrenia are associated with a failure to activate relevant areas in the forebrain and with prominent negative symptoms.

Arms: arm 1: Participants will be maintained on a stable dose of Second Generation Antipsychotic (SGA) and receive 4-8 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) can be titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose must remain stable after Day 42 for the remainder of the study. arm 2: Participants will be maintained on a stable dose of SGA and receive 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) can be titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose must remain stable after Day 42 for the remainder of the study. arm 3: Participants will be maintained on a stable dose of SGA and receive matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
Interventions: intervention 1: MK-8435 (Org 25935) 4-8 mg intervention 2: Placebo intervention 3: MK-8435 (Org 25935) 12-16 mg
Intervention descriptions: intervention 1: Administered orally 2 times a day (BID) for a final concentration of 8-16 mg/day intervention 2: Matching placebo for MK-8435 (Org 25935) administered orally BID intervention 3: Administered orally BID for a final concentration of 24-32 mg/day

Protocol documents:
Clinical trial NCT00746733
Conditions: Healthy Volunteers
Keywords: Drug Interaction Study
Sponsor: Shire
Start date: 2008-09-08; Completion date: 2008-10-26
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine if taking Vyvanse with Prilosec OTC or Adderall XR with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how much of the drug is absorbed into the body.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lisdexamfetamine Dimesylate intervention 2: Adderall XR (mixed salts amphetamine)
Intervention descriptions: intervention 1: 50mg capsule intervention 2: 20mg capsule

Protocol documents:
Clinical trial NCT00536809
Conditions: Neoplasms, Colorectal
Keywords: Metastatic Colorectal Cancer oxaliplatin fluoropyrimidines cancers Advanced Colorectal Cancer capecitabine lapatinib
Sponsor: GlaxoSmithKline
Start date: 2007-09-26; Completion date: 2008-10-31
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the highest, tolerated dose level and safety of lapatinib, capecitabine and oxaliplatin in subjects with advanced cancer and to determine the clinical activity of the combination of drugs in subjects with previously untreated advanced or metastatic colorectal cancer.

Detailed description:

Arms: arm 1: Dose escalation of lapatinib along with capecitabine and oxaliplatin until the maximum tolerated dose is reached. arm 2: Treatinng subjects at the maximum tolerated dose of lapatinib, capecitabine, and oxaliplatin
Interventions: intervention 1: lapatinib intervention 2: oxaliplatin intervention 3: capecitabine
Intervention descriptions: intervention 1: onced daily Days 1-21 intervention 2: Day one of each cycle intervention 3: given BID days 1-14

Protocol documents:
Clinical trial NCT00089895
Conditions: Myocardial Ischemia Acute Coronary Syndrome
Keywords: myocardial infarction acute coronary syndrome non-ST-segment elevation eptifibatide Integrilin glycoprotein IIb/IIIa inhibitor (GP IIb/IIIa) percutaneous coronary intervention (PCI) coronary artery bypass graph surgery (CABG) catheterization angina ischemia cardiac ischemia cardiovascular disease
Sponsor: Organon and Co
Start date: 2004-11-01; Completion date: 2008-11-01
Enrollment: 9406 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention (surgery) compared to placebo (with delayed provisional use of eptifibatide).

Detailed description:
This study will enroll patients who experience symptoms of acute coronary syndrome (experiencing chest pain at rest with episodes lasting at least 10 minutes) and who are planned to undergo invasive surgical procedures after being given study drug for 12 to 96 hours. There are two different treatment groups in this study; approximately half of the patients will go to each group and the likelihood of receiving study drug vs. placebo is 50/50 (like tossing a coin). Medications that are standard of care will be provided to the patients (all patients will be given aspirin and standard hospital doses of one of two other blood thinning drugs - unfractionated heparin (UFH) or low-molecular-weight heparin). Which one patients receive is at the discretion of the Investigator.

Arms: arm 1: Eptifibatide in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin. arm 2: Placebo in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.
Interventions: intervention 1: Eptifibatide (Integrilin) intervention 2: Placebo
Intervention descriptions: intervention 1: intravenous; 180 mcg/kg bolus followed by infusion of 2 mcg/kg/min for 12 to 96 hours (or longer if necessary to complete the 18- to 24-hour post-PCI infusion period, or up to 120 hours in patients who proceed to CABG \[coronary artery bypass graft\]); second bolus of 180 mcg/kg administered 10 minutes after first bolus. intervention 2: intravenous; delivery to match eptifibatide to maintain blind

Protocol documents:
Clinical trial NCT00099268
Conditions: Parkinson's Disease
Keywords: Parkinson's disease, levodopa therapy, dyskinesia
Sponsor: Novartis Pharmaceuticals
Start date: 2004-09-01; Completion date: 2008-11-01
Enrollment: 747 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.

Detailed description:

Arms: arm 1: Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks. arm 2: Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Interventions: intervention 1: Carbidopa/levodopa/entacapone intervention 2: Immediate release carbidopa/levodopa
Intervention descriptions: intervention 1: Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules. intervention 2: Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules.

Protocol documents:
Clinical trial NCT00127166
Conditions: Exercise Induced Asthma
Sponsor: Organon and Co
Start date: 2005-12-01; Completion date: 2008-11-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.

Detailed description:

Arms: arm 1: Period I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study. arm 2: Period I - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
Interventions: intervention 1: Montelukast sodium intervention 2: Salmeterol xinafoate intervention 3: Fluticasone propionate intervention 4: Montelukast matching placebo intervention 5: Salmeterol matching placebo
Intervention descriptions: intervention 1: Montelukast 5 mg chewable tablet once daily intervention 2: Salmeterol 50 mcg dry powder per actuation inhaled twice daily intervention 3: Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily intervention 4: Matching placebo to montelukast oral tablet administered once daily. intervention 5: Matching placebo to salmeterol dry powder for inhalation administered twice daily

Protocol documents:
Clinical trial NCT00213135
Conditions: Multiple Sclerosis, Relapsing-Remitting
Sponsor: EMD Serono
Start date: 2005-04-01; Completion date: 2008-11-01
Enrollment: 1326 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine if cladribine tablets are a safe and effective treatment for relapsing-remitting multiple sclerosis (RRMS).

Detailed description:
This is a randomized, double-blind, three-arm, placebo-controlled, multi-center study. The study includes a pre-study evaluation period (up to 28 days prior to the start of treatment); an initial treatment period from Week 1 to 48; and a re-treatment period during Week 49 to 96.

During the initial treatment period (Week 1 to 48), eligible subjects are equally randomized by a central randomization system to receive either a) cladribine at a low dose (0.875 milligram per kilogram per course \[mg/kg/course\] for two courses plus placebo for two courses); b) cladribine at a high dose (0.875 mg/kg/course for four courses); or c) placebo (four courses). During the re-treatment period (Weeks 49 to 96), subjects received either a) cladribine at a low dose (0.875 mg/kg/course for two courses); or b) placebo (two courses).

For all randomized subjects, there is a rescue option of treatment with Rebif® (interferon beta-1a 44 microgram (mcg) given subcutaneously three times a week), if the subject experienced more than one qualifying relapse, and/or experienced a sustained increase in their EDSS score of greater than or equal to (\>=) 1 point, or \>=1.5 points if baseline EDSS score is 0, (over a period of three months or greater), during a calendar year beginning at Week 24.

To maintain the blind, there is a treating physician who view clinical laboratory results and assess adverse events and safety information, and an independent blinded evaluating physician who will perform neurological exams. A central neuroradiology center, also blinded to treatment, will assess magnetic resonance imaging (MRI) evaluations.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Cladribine 5.25 mg/kg intervention 2: Cladribine 3.5 mg/kg intervention 3: Placebo
Intervention descriptions: intervention 1: Cladribine tablet will be administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks. intervention 2: Cladribine tablet will be administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Weeks 1, 5, 48, and 52 and placebo matched to cladribine tablet will be administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. intervention 3: Placebo matched to cladribine tablet will be administered over a course of 4 or 5 consecutive days of 28-day period at Weeks 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.

Protocol documents:
Clinical trial NCT00283049
Conditions: Diabetes Mellitus, Type 2
Sponsor: Sanofi
Start date: 2006-02-01; Completion date: 2008-11-01
Enrollment: 390 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the change in hemoglobin A1c (HbA1c) from baseline to Week 12 between the 3 treatment arms.

Detailed description:

Arms: arm 1: Arm 1: Insulin glargine administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%) arm 2: Arm 2: Insulin glargine administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%) arm 3: Arm 3: Insulin glargine administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added arms after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
Interventions: intervention 1: Insulin Glargine intervention 2: Insulin Glulisine
Intervention descriptions: intervention 1: Insulin glargine administered subcutaneously once daily. intervention 2: Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)

Protocol documents:
Clinical trial NCT00316082
Conditions: Diabetes
Sponsor: AstraZeneca
Start date: 2006-06-01; Completion date: 2008-11-01
Enrollment: 365 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise

Detailed description:
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (rescue medication) added onto their blinded study medication

Arms: arm 1: PLUS open-label metformin (as needed as rescue medication) arm 2: PLUS open-label metformin (as needed as rescue medication) arm 3: PLUS open-label metformin (as needed as rescue medication) arm 4: PLUS open-label metformin (as needed as rescue medication) arm 5: PLUS open-label metformin (as needed as rescue medication)
Interventions: intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Saxagliptin intervention 4: Saxagliptin intervention 5: Placebo intervention 6: metformin
Intervention descriptions: intervention 1: Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT) intervention 2: Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT) intervention 3: Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT) intervention 4: Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT) intervention 5: Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT) intervention 6: Tablets, Oral, 500-2000 mg, as needed (12 months LT)

Protocol documents:
Clinical trial NCT00394953
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2006-12-01; Completion date: 2008-11-01
Enrollment: 490 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Eligible participants with anemia in CKD who were on hemodialysis will receive methoxy polyethylene glycol-epoetin beta (MIRCERA \[RO0503821\]) IV once every month up to 52 weeks. The starting dose of MIRCERA which will be administered during the treatment period will depend on the dose of darbepoetin alfa administered during screening period i.e., 120, 200 and 360 mcg for weekly darbepoetin alfa doses of \<40, 40-80, and \>80 mcg, respectively. arm 2: Eligible participants with anemia in CKD who were on hemodialysis will receive darbepoetin alfa (Aranesp) IV once every two weeks up to 26 weeks and darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Interventions: intervention 1: Darbepoetin alfa intervention 2: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: As prescribed, iv. intervention 2: 120, 200 or 360 micrograms iv / month, starting dose

Protocol documents: