NCT01129011

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

6-Month, Phase 3, Randomized, Double-blind, Parallel-group, Controlled, Multi-center Study Evaluate Gastric Ulcer Incidence Following Administration of PN400 or Naproxen in Subjects Who Are at Risk for Developing NSAID-associated Ulcers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: POZEN · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Objectives: Primary: To demonstrate that PN400 is effective in reducing the risk of gastric ulcers in subjects at risk for developing NSAID-associated gastric ulcers. Secondary: * To determine if PN400 is effective in reducing the risk of duodenal ulcers in subjects at risk for developing NSAID-associated ulcers * To compare upper gastrointestinal symptoms in subjects treated with PN400 versus naproxen as measured by scores on the Severity of Dyspepsia Assessment (SODA) instrument and the Overall Treatment Evaluation - Dyspepsia (OTE-DP) * To compare heartburn symptoms in subjects treated with PN400 versus naproxen * To evaluate the safety and tolerability of PN400 and naproxen

Conditions

• Gastric Ulcer

Interventions

Type	Name	Description
DRUG	PN400 (VIMOVO)	PN400 tablets (Naproxen 500 mg and Esomeprazole 20 mg) twice daily (bid) taken orally.
DRUG	Naproxen	Naproxen 500 mg dosed twice daily (bid) orally

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-09-01
• Completion: 2008-10-01
• First posted: 2010-05-24
• Last updated: 2010-12-28
• Results posted: 2010-12-28