Clinical trial
Study to Evaluate the Incidence of Gastric Ulcers Following Administration of…
NCT00367211 · POZEN, Industry · Completed
Key facts
| NCT number | NCT00367211 |
|---|---|
| Title | Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers. |
| Official title | A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers. |
| Lead sponsor | POZEN, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis |
| Intervention type | Drug |
| Interventions | PN 200 tablets (500 mg naproxen and 20 mg omeprazole), Naproxen 500 mg tablets (PN 200 minus omeprazole) |
| Enrollment | 400 |
| Start date | Sep 1, 2006 |
| Primary completion | Sep 1, 2007 |
| Completion | Sep 1, 2007 |
| First posted | Aug 22, 2006 |
| Last update posted | Apr 22, 2008 |
| Countries | United States |
At a glance
- 1–9 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: