Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec
Status:
Terminated
Trial end date:
2008-09-01
Target enrollment:
Participant gender:
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.