NCT00594854

Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec

6-Month, Randomized, Double-blind, Parallel-group, Controlled, Multi-center Study of Gastric Ulcer Incidence With PN400 (Esomeprazole/Naproxen) Versus Diclofenac/Misoprostol in Subjects at High Risk for Developing NSAID-Associated Ulcers

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: POZEN · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized, double-blind, parallel-group, controlled, multi-center clinical trial of 6 months duration is designed to assess the efficacy, tolerability and safety of PN400 versus diclofenac/misoprostol in subjects at high risk for developing NSAID-associated gastric ulcers. Approximately 100 sites will participate to enroll a total of 200 subjects (100 per arm). At least 20% of the subjects enrolled will be age 65 years and older.

Detailed description

To determine the incidence of gastric ulcers following administration of PN 400 in a high risk population over six months. Diclofenac/misoprostol will be used as a positive control. Secondary: * To determine the incidence of duodenal ulcers during treatment with PN 400 and diclofenac/misoprostol in a high risk population * To evaluate the degree of upper gastrointestinal injury as measured by Lanza scores (1991) during treatment with PN400 and diclofenac/misoprostol in a high risk population * To compare gastrointestinal symptoms in subjects treated with PN 400 versus diclofenac/misoprostol as measured by scores on the Gastrointestinal Symptoms Rating Scale (GSRS) instrument * To evaluate the safety and tolerability of PN400 and diclofenac/misoprostol in a high risk population

Conditions

• Gastric Ulcer

Interventions

Type	Name	Description
DRUG	PN400 (VIMOVO)	PN400 tablet (500 mg delayed-release naproxen/20 mg immediate-release esomeprazole) given by mouth twice daily (bid).
DRUG	Diclofenac/Misoprostol	Over-encapsulated ARTHROTEC® 75 (75 mg diclofenac sodium/200 mcg misoprostol) capsules given by mouth bid.

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-01-16
• Last updated: 2010-09-22
• Results posted: 2010-09-22

Locations

1 site across 1 country: United States