Trials / Completed
CompletedNCT00441519
A Parallel Group Study to Compare the Gastroprotective Effects of PA 325 Versus 81 mg Enteric Coated Aspirin
An Open-Label, Investigator-Blinded, Stratified, Randomized, Parallel Group Study to Compare the Gastroprotective Effects of PA 325 Versus 81 mg Enteric Coated Aspirin
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- POZEN · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
Summary
To compare the gastroprotective effects of a once-daily dose of PA 325 combination tablet
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | aspirin | |
| DRUG | omeprazole |
Timeline
- Start date
- 2007-02-01
- Primary completion
- 2007-04-01
- Completion
- 2007-04-01
- First posted
- 2007-03-01
- Last updated
- 2009-01-12
Locations
2 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00441519. Inclusion in this directory is not an endorsement.