A Parallel Group Study to Compare the Gastroprotective Effects of PA 325 Versus 81 mg Enteric Coated Aspirin
To compare the gastroprotective effects of a once-daily dose of PA 325 combination tablet
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Investigator-Blinded, Stratified, Randomized, Parallel Group Study to Compare the Gastroprotective Effects of PA 325 Versus 81 mg Enteric Coated Aspirin|
- The primary endpoint is the occurrence of gastric and/or duodenal bulb lesions meeting Grade 3 or Grade 4 Lanza (1988) scores for the stomach and duodenal bulb (combined).
- Secondary endpoints include the incidence of gastric and/or duodenal ulcers, total number of gastric and/or duodenal erosions, gastric pH and any other GI tolerability issues.
|Study Start Date:||February 2007|
|Study Completion Date:||April 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
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 81 mg enteric coated (EC) aspirin utilizing Lanza scores from endoscopy findings in normal healthy volunteers.
Secondary: To evaluate the safety and gastrointestinal tolerability, including ulcerogenic potential, and the effect on gastric pH of PA 325.
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27517|
|MDS Pharma Services|
|Montreal, Quebec, Canada, H4R2N6|
|Study Director:||Judy Bryson, Pharm. D.||POZEN|