CLINICAL TRIALS PROFILE FOR ASPIRIN; OMEPRAZOLE
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All Clinical Trials for Aspirin; Omeprazole
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00349661 ↗ | Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel | Completed | University Hospital, Brest | Phase 3 | 2006-06-01 | Objectives: A prospective investigation of the effect of omeprazole, a proton pump inhibitor, on the anti-platelet action of clopidogrel. The main decision criterion will concern change in VASP protein phosphorylation under treatment. Phosphorylation will be measured before and after administration of omeprazole versus placebo in patients undergoing clopidogrel treatment. Type of study: Single center, double blind, randomized parallel group study versus placebo, comparing two treatment groups: - clopidogrel + omeprazole + standard regime (beta-blockers, atorvastatin, IEC, aspirin) - clopidogrel + placebo+ standard regime (beta-blockers, atorvastatin, IEC, aspirin) Study population: 120 patients from the Cardiology Department of Brest University hospital, Brest (France), receiving a standard treatment comprising a loading dose of clopidogrel followed by a daily dose of 75 mg associated to 75 mg aspirin, will be randomized between 20 mg/day omeprazole and 20 mg/day placebo treatment groups. The efficacy of clopidogrel will be assessed by inter-group comparison on the VASP test. Study period: 7 days' treatment per patient. Total study period estimated at 6 months. Expected findings: The results should confirm the suspected negative effect of omeprazole on clopidogrel's impact on arterial thrombosis risk, secondarily allowing new recommendations to be drawn up for this association. |
| NCT00441519 ↗ | A Parallel Group Study to Compare the Gastroprotective Effects of PA 325 Versus 81 mg Enteric Coated Aspirin | Completed | POZEN | Phase 1 | 2007-02-01 | To compare the gastroprotective effects of a once-daily dose of PA 325 combination tablet |
| NCT00442052 ↗ | To Compare the Gastroprotective Effects and Pharmacokinetic Profile of PA Versus Enteric-Coated Aspirin | Completed | POZEN | Phase 1 | 2006-11-01 | Primary: To compare the gastroprotective effects of a once-daily dose of PA 325 combination tablet combining 325 mg pH sensitive aspirin and 20 mg immediate release omeprazole versus a once-daily dose of 325 mg enteric coated aspirin utilizing Lanza scores from endoscopy findings in normal healthy volunteers. |
| NCT00557921 ↗ | Clopidogrel and the Optimization of Gastrointestinal Events (COGENT-1) | Terminated | Cogentus Pharmaceuticals | Phase 3 | 2007-12-01 | The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of gastrointestinal bleeding and symptomatic ulcer disease, in the setting of concomitant aspirin therapy. Antiplatelet therapy is an essential element of care for patients with atherothrombotic disease. Bleeding is a fundamental adverse effect of all antiplatelet drugs including aspirin, clopidogrel and dual antiplatelet regimens. The gastrointestinal tract is the most common site of bleeding related to antiplatelet therapy, typically in connection with peptic ulcer disease. Recently published studies suggest the use of clopidogrel carries a gastrointestinal bleeding risk similar to that of aspirin or non-aspirin non-steroidal anti-inflammatory drugs. Patients taking any two of these drugs (clopidogrel, aspirin and/or non-aspirin NSAIDs) are exposed to an even higher risk of bleeding and ulcer disease. Cogentus Pharmaceuticals is launching phase 3 trials of a novel combination product, CGT-2168, which has the potential to significantly reduce this problem and increase patient safety. CGT-2168 combines a standard dosage of clopidogrel and a gastroprotectant (omeprazole) in a once-daily pill that may reduce the likelihood of adverse gastrointestinal events. |
| NCT00632086 ↗ | Evaluate Relative Bioavailability of PA32540 (Asa/Omeprazole), Its Aspirin Component, and Ecotrin® in Healthy Volunteers | Completed | POZEN | Phase 1 | 2008-02-01 | Study to determine a single dose bioavailablity of PA32540 is similar to EC aspirin 325 mg with respect to salicylic acid. |
| NCT00858858 ↗ | Clinical Studies on Bile Acids in Barrett's Esophagus | Completed | US Department of Veterans Affairs | N/A | 2009-03-01 | This study has two major goals: 1. To determine the effects of bile salts on causing DNA injury and activating signaling pathways that promote growth in cells from the esophagus of patients who have gastroesophageal reflux disease (GERD) 2. To determine whether changes in bile composition induced by treating patients with a bile salt called ursodeoxycholic acid (UDCA) can alter DNA injury, signaling pathway activation and other types of damage in cells from the esophagus of patients who have GERD. |
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