drugset / Trial / NCT00527787

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

NCT00527787

Phase 3 Completed 434 enrolled POZEN
RandomizedParallel-groupDouble-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Esomeprazole Small molecule 20 mg Oral
Comparator Naproxen Small molecule 500 mg Oral

Indications