drugset / Trial / NCT00960869

Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers

NCT00960869

Phase 3 Completed 519 enrolled POZEN
RandomizedParallel-groupDouble-blindTreatment

Summary

Primary: To demonstrate that PA32540 causes fewer gastric ulcers in subjects at risk for developing aspirin-associated gastric ulcers compared to enteric coated (EC) aspirin 325 mg.

Timeline

Start
2009-10
Primary completion
2012-02
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 325 mg
Subject Omeprazole Other / unclassified 40 mg

Indications