ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01413204
Conditions: Type 2 Diabetes Mellitus
Keywords: TA-7284 JNJ-28431754 Canagliflozin Sodium Glucose Co-transporter (SGLT2 inhibitor)
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2011-07-01; Completion date: 2012-08-01
Enrollment: 272 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy in patients with type 2 Diabetes for 24 weeks administration.

Detailed description:
This is a randomized, 3-arm, parallel group, double blind study to evaluate the efficacy and safety of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will receive either TA-7284-Low, TA-7284-High or Placebo orally alone for 24 weeks.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: TA-7284 Low intervention 2: TA-7284 High intervention 3: Placebo
Intervention descriptions: intervention 1: The patients will receive TA-7284-Low orally for 24 weeks. intervention 2: The patients will receive TA-7284-High orally for 24 weeks. intervention 3: The patients will receive Placebo orally for 24 weeks.

Protocol documents:
Clinical trial NCT01432535
Conditions: Renal Insufficiency
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-11-01; Completion date: 2012-08-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the pharmacokinetics of a single dose of peginterferon alfa-2b (Sylatron®) in healthy participants to that in participants with moderate to severe impairment of kidney function.

Detailed description:

Arms: arm 1: Participants with normal renal function defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. arm 2: Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. arm 3: Participants with severe renal impairment defined as having a creatinine clearance test value of \<30 mL/min/1.73 m\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
Interventions: intervention 1: PegIFN-2b (Sylatron®)
Intervention descriptions: intervention 1: Single 4.5 μg/kg dose

Protocol documents:
Clinical trial NCT01436071
Conditions: Asthma
Sponsor: GlaxoSmithKline
Start date: 2011-09-01; Completion date: 2012-08-01
Enrollment: 248 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents not currently receiving inhaled corticosteroids

Detailed description:
This will be a multi-centre, randomised, placebo controlled (with rescue medication), double-blind, parallel group study. Subjects meeting all the inclusion criteria and none of the exclusion criteria during Visit 1 (Screening Visit) will enter a two week Run-in Period. Subjects failing screening will not be eligible for re-screening. During the run-in and double-blind treatment periods subjects will maintain an electronic daily diary to record morning and evening peak expiratory flow (PEF), asthma symptom score and rescue albuterol/salbutamol use. At Visit 2 (end of run-in/Randomisation Visit), subjects meeting the eligibility criteria will be randomised to either inhaled Fluticasone Furoate 50 mcg or inhaled placebo. In addition all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as required to treat symptoms. Subjects will attend 4 on-treatment visits at Visits 3, 4, 5, and 6 (Weeks 2, 4, 8 and 12 respectively). Subjects will receive treatment for 84 days (12 weeks). A follow-up contact will be performed 1-week after completing study medication (Visit 7). Subjects will participate in the study for up to a maximum of 15 weeks (including screening, treatment and follow-up contact).

Arms: arm 1: Inhalation powder delivered by Novel Dry Powder Inhaler arm 2: Inhalation powder delivered by Novel Dry Powder Inhaler
Interventions: intervention 1: Fluticasone furoate 50mcg intervention 2: Placebo
Intervention descriptions: intervention 1: Inhalation powder delivered by Novel Dry Powder Inhaler intervention 2: Inhalation powder delivered by Novel Dry Powder Inhaler

Protocol documents:
Clinical trial NCT01440101
Conditions: Multiple Sclerosis
Sponsor: Biogen
Start date: 2010-11-01; Completion date: 2012-08-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of Part A is to determine the safety and tolerability of natalizumab administered over 24 weeks in Japanese participants with relapsing-remitting multiple sclerosis (MS). The endpoints for this will include assessment of adverse evetns (AEs), changes in laboratory evaluations, vital signs, Expanded Disability Status Scale (EDSS) scores, and changes in physical and neurological examination findings. The secondary objectives of Part A are to characterize the pharmacokinetics (PK) profile and pharmacodynamics (PD) of natalizumab.

The primary objective of Part B is to determine if natalizumab, when compared to placebo, is effective in treating Japanese participants with relapsing-remitting MS, as measured by new active lesions on cranial magnetic resonance imaging (MRI) scans over 24 weeks. New active lesions are the sum of the gadolinium-enhancing (Gd+) lesions and any new or newly-enlarging T2-hyperintense lesions that do not enhance. The primary endpoint is the rate of development of new active lesions over 24 weeks.

Secondary objectives of Part B are to determine over 24 weeks whether natalizumab, when compared to placebo, is effective in reducing the frequency of clinical exacerbations, reducing the number of Gd+ lesions, reducing the number of new or newly-enlarging T2-hyperintense lesions on brain MRI scans, increasing the proportion of relapse-free participants, and improving outcomes on visual analog scale (VAS) assessing the participant's global impression of his/her well-being. Additional objectives are to assess the safety and tolerability, the incidence of serum antibodies to natalizumab and the PK profile of natalizumab.

Detailed description:
This multicenter study has 2 parts and is designed to provide data in Japanese participants, as required for registration of natalizumab (BG00002) in Japan. Part A will consist of an open-label cohort of 12 participants who will receive 300 mg natalizumab intravenously (IV) every 4 weeks over a 6-month treatment period. Part B will consist of a double-blind, placebo-controlled cohort of approximately 90 participants randomized in a ratio of 1:1 to receive IV infusions of placebo or 300 mg BG00002 every 4 weeks over a 6-month period.

Arms: arm 1: 300 mg IV infusions of natalizumab over 60 minutes every 4 weeks for 20 weeks arm 2: IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks arm 3: 300 mg IV infusions of natalizumab over 60 minutes every 4 weeks for 20 weeks
Interventions: intervention 1: Natalizumab (BG00002) intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01453855
Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Open-Angle Glaucoma Ocular Hypertension
Sponsor: Alcon Research
Start date: 2011-11-01; Completion date: 2012-08-01
Enrollment: 1099 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma or ocular hypertension.

Detailed description:
This study consisted of six visits conducted during two sequential phases. The Screening/Eligibility phase included one screening visit and two eligibility visits. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1) at the second eligibility visit. The Treatment phase consisted of three on-therapy visits (Week 2, Week 6, and Month 3).

Arms: arm 1: Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months arm 2: Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
Interventions: intervention 1: Travoprost ophthalmic solution, 0.003% intervention 2: Travoprost ophthalmic solution, 0.004%
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01462435
Conditions: Other Acute Postoperative Pain
Sponsor: Iroko Pharmaceuticals, LLC
Start date: 2011-10-01; Completion date: 2012-08-01
Enrollment: 428 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Diclofenac \[Test\] Capsules are safe and effective for the treatment of bunionectomy pain.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Diclofenac Test (lower dose) intervention 2: Diclofenac Test (upper dose) intervention 3: Celecoxib intervention 4: Placebo
Intervention descriptions: intervention 1: Capsules intervention 2: Capsules intervention 3: 200 mg Capsules intervention 4: Capsules

Protocol documents:
Clinical trial NCT01473732
Conditions: Chronic Allograft Injury Calcineurin Inhibitor Toxicity
Keywords: CNI toxicity CAI
Sponsor: Montefiore Medical Center
Start date: 2012-03-01; Completion date: 2012-08-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out how well the current drug regimen (including low Prograf dose and Myfortic, which is usually recommended to prevent any further deterioration in the kidney function) works and how safe it is when compared to a combination of Zortress and Myfortic in patients with chronic kidney injury associated with Prograf or Neoral use.

Detailed description:
Specific Aim 1: To investigate allograft and peripheral blood cell gene expression patterns of patients with CAI by using Affymetrix microarrays.

Hypothesis 1: Gene expression patterns of patients with biopsy findings suggesting calcineurin inhibitor (CNI) toxicity without significant tubulointerstitial infiltrates or transplant glomerulopathy might demonstrate upregulation of genes related to tissue injury, fibrosis, and extracellular matrix deposition without upregulation of genes related to alloimmune response, such as, T and/or B lymphocyte activation markers, surface receptors, co-stimulation molecules, adhesion molecules, cytokines, and chemokines comparing to patients with significant tubulointerstitial infiltrates and/or transplant glomerulopathy that might show upregulation of genes related to alloimmune response, such as, T and/or B lymphocyte activation markers, surface receptors, co-stimulation molecules, adhesion molecules, cytokines, and chemokines.

Specific Aim 2: The effect of everolimus (Zortress)/ mycophenolate sodium (EC-MPS, myfortic®) treatment on allograft and peripheral gene expression patterns.

Hypothesis 2: Everolimus (Zortress) and mycophenolate sodium (EC-MPS, myfortic®) treatment attenuates the progression of CAI due to CNI toxicity by downregulating the expression of genes related to fibrosis, such as, transforming growth factor-β, thrombospondin 1, and platelet derived growth factor-C.

Specific Aim 3: To document the clinical outcomes of everolimus (Zortress) and mycophenolate sodium (EC-MPS, myfortic®) in patients with CAI due to CNI toxicity Hypothesis 3: Everolimus (Zortress) and mycophenolate sodium (EC-MPS, myfortic®) can attenuate the progression of CAI due to CNI toxicity and may improve the creatinine clearance.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Everolimus intervention 2: Tacrolimus intervention 3: Mycophenolic acid
Intervention descriptions: intervention 1: Starting dose 1.5 mg bid, target trough level 6-10 ng/ml. intervention 2: Target trough level of Tacrolimus 3-5 ng/ml. intervention 3: Myfortic Min. dose 360 mg bid and Max dose 720 mg bid. Used in both arms. Used for one year.

Protocol documents:
Clinical trial NCT01478620
Conditions: Urinary Tract Infection
Sponsor: Bionorica SE
Start date: 2011-10-01; Completion date: 2012-08-01
Enrollment: 125 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of the study is to assess safety and impact of a non-antibiotic therapy approach with Canephron® N in the management strategy of uncomplicated lower urinary tract infections (UTIs).

Detailed description:
250 patients total 7-day treatment period with Canephron® N (2 tablets three times a day) and a follow-up period until Day 37. A total of three visits are planned on Day 0 (screening, start of study treatment), Day 7 (end of study treatment) and Day 37 (end of study visit).

Additional visits can be performed anytime between Day 1 and Day 37 if deemed necessary by the investigator. In case the patients experience consistent or worsening of symptoms they may be offered antibiotic therapy at the discretion of the investigator at any time. In this case Canephron® N intake will be stopped.

At least 50% of the patients, i.e. 125 subjects, should have received a 7-day treatment with Canephron® N. If less subjects are available recruitment of subjects will be continued until the required number of 125 subjects is reached.

Due to withdrawal of study in Russia total study population was reduced to 125 patients.

Arms: arm 1: None
Interventions: intervention 1: Canephron® N
Intervention descriptions: intervention 1: 3x 2 coated tablets/day for 7 days p.o.

Protocol documents:
Clinical trial NCT01489891
Conditions: Esophagogastroduodenoscopy
Keywords: Esophagogastroduodenoscopy Lidocaine Propofol
Sponsor: Hospital Universitario Infanta Cristina
Start date: 2011-12-01; Completion date: 2012-08-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of application of the anaesthesia topical pharyngeal with lidocaine in esophagogastroduodenoscopy under propofol´s sedation, in therms of dosage and side effect´s reduction overall.

Detailed description:

Arms: arm 1: Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD) arm 2: Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.
Interventions: intervention 1: Lidocaine intervention 2: Placebo
Intervention descriptions: intervention 1: Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff). intervention 2: Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking).

Protocol documents:
Clinical trial NCT01490125
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Dyspnea QVA149 tiotropium
Sponsor: Novartis Pharmaceuticals
Start date: 2011-10-01; Completion date: 2012-08-01
Enrollment: 247 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study assessed the effect of QVA149 on patient-reported dyspnea in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.

Detailed description:
This study used a multi-center, randomized, blinded, double-dummy placebo controlled, three-period crossover design to assess the effect of once daily QVA149 q.d vs. placebo and tiotropium 18 μg q.d. in terms of patient reported dyspnea as assessed by Baseline Dyspnea Index (BDI)/Transient Dyspnea Index (TDI)(SAC version) in patients with moderate to severe COPD.

Arms: arm 1: Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication. arm 2: Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication. arm 3: Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
Interventions: intervention 1: QVA149 intervention 2: Tiotropium intervention 3: Placebo to QVA149 intervention 4: Placebo to tiotropium intervention 5: Salbutamol/albuterol
Intervention descriptions: intervention 1: QVA149 110/50 μg hard non-gelatin capsule, inhalation/blister once a day via SDDPI intervention 2: Tiotropium 18 ug hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device intervention 3: Placebo 0 mg hard non-gelatin capsule, inhalation/ blister once a day via SDDPI intervention 4: Placebo 0 mg hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device intervention 5: salbutamol/albuterol (containing CFC-free propellant -HFA 134a) inhaler used as rescue medication when needed.

Protocol documents:
Clinical trial NCT01493596
Conditions: Cocaine Dependency
Keywords: Safety Tolerability
Sponsor: Catalyst Pharmaceuticals, Inc.
Start date: 2011-12-01; Completion date: 2012-08-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

• To evaluate the safety and tolerability of ascending single oral doses of CPP-115

Secondary Objective:

• To determine the pharmacokinetic profiles of CPP-115 following administration of a ascending single oral doses

Detailed description:

Arms: arm 1: Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. arm 2: 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. arm 3: Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. arm 4: Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. arm 5: Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. arm 6: Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose.
Interventions: intervention 1: CPP-115 intervention 2: Placebo
Intervention descriptions: intervention 1: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing. intervention 2: An equal volume of water mixed with juice will be administered.

Protocol documents:
Clinical trial NCT01507246
Conditions: Bowel Obstruction
Keywords: open colectomy
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2011-12-01; Completion date: 2012-08-01
Enrollment: 42 participants; Allocation: NON_RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This study is designed to compare the standard of care against EXPAREL(R) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospitalization costs.

Detailed description:
This is a phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with EXPAREL compared with postsurgical administration of standardized intravenous (IV) morphine sulfate or sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing open colectomy with general anesthesia.

Arms: arm 1: Standard of Care (SOC), dosage variable, administered intravenously via PCA pump postsurgically, as need. arm 2: EXPAREL(R), dosage 266 mg, diluted with 0.9% saline to a total volume of 40 cc.
Interventions: intervention 1: IV morphine sulfate intervention 2: EXPAREL (bupivacaine liposome injectable suspension)
Intervention descriptions: intervention 1: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. intervention 2: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.

All patients will be offered rescue analgesia, as needed.

Protocol documents: