Gastric Ulcer Clinical Trial
Official title:
6-Month, Randomized, Double-blind, Parallel-group, Controlled, Multi-center Study of Gastric Ulcer Incidence With PN400 (Esomeprazole/Naproxen) Versus Diclofenac/Misoprostol in Subjects at High Risk for Developing NSAID-Associated Ulcers
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.
To determine the incidence of gastric ulcers following administration of PN 400 in a high
risk population over six months. Diclofenac/misoprostol will be used as a positive control.
Secondary:
- To determine the incidence of duodenal ulcers during treatment with PN 400 and
diclofenac/misoprostol in a high risk population
- To evaluate the degree of upper gastrointestinal injury as measured by Lanza scores
(1991) during treatment with PN400 and diclofenac/misoprostol in a high risk population
- To compare gastrointestinal symptoms in subjects treated with PN 400 versus
diclofenac/misoprostol as measured by scores on the Gastrointestinal Symptoms Rating
Scale (GSRS) instrument
- To evaluate the safety and tolerability of PN400 and diclofenac/misoprostol in a high
risk population
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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