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Generated: December 19, 2018

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CLINICAL TRIALS PROFILE FOR ASPIRIN; OMEPRAZOLE

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Clinical Trials for Aspirin; Omeprazole

Trial ID Title Status Sponsor Phase Summary
NCT00349661 Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel Completed University Hospital, Brest Phase 3 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 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 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 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 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 VA Office of Research and Development N/A 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.
NCT01061034 Pharmacological Study That Measures Omeprazole Effect on Aspirins Absorption in Healthy Volunteers Completed Assaf-Harofeh Medical Center N/A Aspirin is a weak acid that crosses the gastric and intestinal mucosa by passive diffusion while in its lipophilic nature.Omeprazole, a proton pump inhibitor, inhibits gastric acid secretion. We assumed that omeprazole inhibits aspirin absorption, thus reducing its action on platelets. healthy volunteers, with no known peptic disease or bleeding disorders will be enrolled. All volunteers will receive 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole 20mg twice daily for 3 days and then 20mg once daily. Blood levels of Aspirin will be determined by High performance liquid chromatography (HPLC), 0, 1, 2, 4, 6, 10, 24 hours after the administration of Aspirin alone on day 7 and Aspirin plus Omeprazole on day 21. Platelet function tests will be determined by platelet-rich plasma aggregometry in response to Arachidonic acid (500mg/ml), Ristocetin (1.5mg/ml) and Adenosine 5'-diphosphate (20mM) on day 0 as baseline and on day 7 and 21 of the study.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Aspirin; Omeprazole

Condition Name

Condition Name for Aspirin; Omeprazole
Intervention Trials
Healthy 3
Percutaneous Coronary Intervention 1
Acute Coronary Syndrome 1
Coronary Heart Disease 1
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Condition MeSH

Condition MeSH for Aspirin; Omeprazole
Intervention Trials
Acute Coronary Syndrome 2
Myocardial Ischemia 2
Coronary Disease 2
Barrett Esophagus 2
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Clinical Trial Locations for Aspirin; Omeprazole

Trials by Country

Trials by Country for Aspirin; Omeprazole
Location Trials
United States 48
Canada 9
Australia 6
Mexico 3
France 2
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Trials by US State

Trials by US State for Aspirin; Omeprazole
Location Trials
North Carolina 3
Texas 2
Maryland 2
Florida 2
Arizona 1
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Clinical Trial Progress for Aspirin; Omeprazole

Clinical Trial Phase

Clinical Trial Phase for Aspirin; Omeprazole
Clinical Trial Phase Trials
Phase 4 2
Phase 3 3
Phase 1 7
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Clinical Trial Status

Clinical Trial Status for Aspirin; Omeprazole
Clinical Trial Phase Trials
Completed 11
Unknown status 2
Terminated 1
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Clinical Trial Sponsors for Aspirin; Omeprazole

Sponsor Name

Sponsor Name for Aspirin; Omeprazole
Sponsor Trials
POZEN 4
Hadassah Medical Organization 2
Bristol-Myers Squibb 1
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Sponsor Type

Sponsor Type for Aspirin; Omeprazole
Sponsor Trials
Other 9
Industry 7
U.S. Fed 1
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