Conditions: Gastric Ulcer
Keywords: NSAID gastric ulcers Vimovo Naproxen Esomeprazole
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 434
Healthy volunteers: no

Brief 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

Arms:
arm 1: Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily arm 2: Naproxen 500 mg dosed twice daily

Interventions: intervention 1: PN400 (VIMOVO) intervention 2: Naproxen
Intervention descriptions: intervention 1: PN400 tablets (Naproxen 500 mg and Esomeprazole 20 mg) twice daily (bid) taken orally. intervention 2: Naproxen (500 mg) dosed twice daily (bid) orally

Protocol document: