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NCT ID: NCT00679380 Completed - Ulcerative Colitis Clinical Trials

(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis

Start date: June 2008
Phase: Phase 3
Study type: Interventional

This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment period. After the screening visit, patients will enter a washout period of 2 days, then they will be randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg), budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and capsules), all administered once a day after breakfast. Hence, each patient will receive, in the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three placebo Entocort® matching capsules.

NCT ID: NCT00674973 Completed - Pancreatic Cancer Clinical Trials

A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer

Start date: June 2008
Phase: Phase 2
Study type: Interventional

This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

NCT ID: NCT00668759 Completed - Atrial Fibrillation Clinical Trials

A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation

AVRO
Start date: April 2008
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to demonstrate the superiority of vernakalant injection over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus rhythm (SR) within 90 minutes of the start of drug administration. The secondary objective is to compare the safety of vernakalant to amiodarone.

NCT ID: NCT00658775 Completed - Clinical trials for Gastroesophageal Reflux Disease (GERD)

Rabeprazole Extended-Release, 50 mg, Versus Esomeprazole, 40 mg, for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)

Start date: February 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the efficacy (ie, healing and symptom relief) and safety of Rabeprazole Extended-Release (RAB ER) 50 mg versus Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).

NCT ID: NCT00658528 Completed - Clinical trials for Gastroesophageal Reflux Disease (GERD)

Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)

Start date: February 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD).

NCT ID: NCT00656890 Completed - Ulcerative Colitis Clinical Trials

A Study of MDX-1100 in Subjects With Active Ulcerative Colitis

MDX1100-06
Start date: April 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in patients administered MDX-1100.

NCT ID: NCT00656747 Completed - Chronic Bronchitis Clinical Trials

Moxifloxacin Versus Amoxicillin Clavulanic Acid in Treatment of Acute Exacerbation of Chronic Bronchitis

Start date: March 2008
Phase: Phase 4
Study type: Interventional

A study to assess the safety and efficacy of moxifloxacin compared to that of amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbation of chronic bronchitis.

NCT ID: NCT00653185 Completed - Diabetes Mellitus Clinical Trials

Efficacy of SYR-472 in Subjects With Type 2 Diabetes Mellitus

Start date: May 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy, safety and tolerability of SYR-472, once daily (QD), in subjects with Type 2 Diabetes Mellitus.

NCT ID: NCT00647504 Completed - Stent Thrombosis Clinical Trials

Prospective Clinical Observational Registry Including Consecutive Patients With In-stent Restenosis or Stent Thrombosis

NIVUS
Start date: October 2007
Phase: N/A
Study type: Observational

Prospective clinical observational registry study including consecutive patients with clinical signs or symptoms due to in-stent restenosis (ISR) or definite (ARC criteria) stent thrombosis (ST). Study hypothesis: Initial Stent implantation quality (due to technique/problems) are possible major determinants of ST and ISR in real life practice. Both early, late, and very late ST, and ISR are important factors for long term outcome after initial stent implantation. Primary objective: - To elucidate the possible cause(s) of thrombosis or restenosis after stent implantation in real life practice by clinical, angiographic and IVUS evaluation. Secondary objective: - To describe the clinical manifestation [stable angina pectoris (AP), unstable AP, non-ST-elevation myocardial infarction (NSTEMI), or ST-elevation MI] of the index event (inclusion). - To describe the characteristics of patient, lesion and procedure of the initial percutaneous coronary intervention (PCI). - To describe the antithrombotic pharmacological therapy preceding the index event. - To describe clinical outcome (death, MI, revascularization, CCS angina class) following treatment of the index event during 12 month follow-up. - To describe safety of the IVUS procedure (product or procedural related complications/ malfunctions).

NCT ID: NCT00645099 Completed - Schizophrenia Clinical Trials

A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia

Start date: October 2007
Phase: Phase 3
Study type: Interventional

The purpose of this 6 month study is to compare the metabolic effects of paliperidone ER and olanzapine in patients with schizophrenia, using the ratio of the concentration of lipids (triglycerides (TG)) in the blood to the concentration of good cholesterol (high density lipoproteins (HDL)) in the blood as the primary parameter. Approximately 456 adult patients will participate in this study.