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Sponsored by: |
Pozen |
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Information provided by: | Pozen |
ClinicalTrials.gov Identifier: | NCT00442052 |
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.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: aspirin Drug: omeprazole |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Investigator-Blinded, Randomized, Parellel Group Study to Compare the Gastroprotective Effects and Pharmacokinetic Profile of PA 325 Versus Enteric-Coated Aspirin. |
Estimated Enrollment: | 80 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | January 2007 |
PA 325 is proposed for the reduction in the risk of aspirin-associated gastrointestinal (GI) adverse events in patients requiring daily aspirin. This study is designed as a Proof of Concept study to evaluate the gastroprotective effects, pharmacokinetic profile, and safety of PA 325 in healthy volunteers.
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.
Ages Eligible for Study: | 50 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
A subject will be eligible for inclusion in this study if all of the following criteria apply:
Female subjects are eligible for participation in the study if they are of:
Childbearing potential, have a negative pregnancy test (urine) at screening, and at least one of the following applies or is agreed to by the subject:
Exclusion Criteria:
Subjects who, through completion of the study, would have donated in excess of:
United States, North Carolina | |
POZEN | |
Chapel Hill, North Carolina, United States, 27517 | |
Canada, Quebec | |
MDS Pharma Services | |
Montreal, Quebec, Canada, H4R2N6 |
Principal Investigator: | Gaetano Morelli, MD | MDS Pharma Services |
Study ID Numbers: | PA325-101 |
Study First Received: | February 27, 2007 |
Last Updated: | February 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00442052 History of Changes |
Health Authority: | Canada: Health Canada |
Gastroprotective effects Aspirin |
Anti-Inflammatory Agents Cyclooxygenase Inhibitors Omeprazole Fibrinolytic Agents Healthy Cardiovascular Agents Fibrin Modulating Agents |
Aspirin Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Platelet Aggregation Inhibitors Analgesics Peripheral Nervous System Agents Antirheumatic Agents |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Hematologic Agents Physiological Effects of Drugs Gastrointestinal Agents Omeprazole Enzyme Inhibitors Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions Fibrin Modulating Agents |
Aspirin Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Ulcer Agents Platelet Aggregation Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |