drugset / Trial / NCT00367211

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.

NCT00367211

Phase 3 Completed 400 enrolled POZEN
RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is 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.

Timeline

Start
2006-09
Primary completion
2007-09
Completion
2007-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Omeprazole Other / unclassified 20 mg
Background Naproxen Small molecule 500 mg