Study Evaluating the Gastrointestinal Safety of PLA-695 Compared to Placebo and Naproxen
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT00366262
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
The purpose of this study is to provide an initial assessment of the gastrointestinal safety of a 7-day regimen of PLA-695 compared to placebo or naproxen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Healthy men or women of nonchildbearing potential, aged 18 to 60 years.
Exclusion Criteria
- Abnormal baseline endoscopy.
- Positive Helicobacter pylori serology.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The rate of erosions and ulcers present after 7 days of treatment for PLA-65 will be compared to placebo and naproxen.
- Secondary Outcome Measures
Name Time Method