Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen

Summary

This study uses a randomized, double-blind, controlled design to demonstrate that PN400 (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric ulcers compared to naproxen alone.

Timeline

Start

2007-09

Primary completion

2008-10

Completion

2008-10

Outcome

Met primary endpoint

registry analysis (superiority or other test); PN400 (VIMOVO) vs Naproxen; p = 0.001; proportions 4.1 (95% CI 1.9 to 7.7); Cochran-Mantel-Haenszel NCT00527787 ↗

Drugs

Indications