drugset / Trial / NCT00594854
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec
RandomizedParallel-groupDouble-blindTreatment
Summary
This randomized, double-blind, parallel-group, controlled, multi-center clinical trial of 6 months duration is designed to assess the efficacy, tolerability and safety of PN400 versus diclofenac/misoprostol in subjects at high risk for developing NSAID-associated gastric ulcers. Approximately 100 sites will participate to enroll a total of 200 subjects (100 per arm). At least 20% of the subjects enrolled will be age 65 years and older.
Timeline
- Start
- 2007-09
- Primary completion
- 2008-09
- Completion
- 2008-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Diclofenac | Other / unclassified | 75 mg | Oral |
| Subject | Esomeprazole | Small molecule | 20 mg | Oral |
| Comparator | Misoprostol | Other / unclassified | 200 ug | Oral |
| Subject | Naproxen | Small molecule | 500 mg | Oral |