A 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

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

Outcome

Met primary endpoint

registry analysis (superiority or other test); PA32540 vs EC Aspirin; p = 0.020; Proportions 3.8 (95% CI 1.8 to 6.8); Cochran-Mantel-Haenszel NCT00961350 ↗

Drugs

Indications