NCT00367211

Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.

A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (planned)
• Sponsor: POZEN · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the incidence of gastric ulcers following administration of either PN 200 or Naproxen in subjects who are at risk for developing NSAID-associated ulcers.

Conditions

• Osteoarthritis
• Rheumatoid Arthritis
• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	PN 200 tablets (500 mg naproxen and 20 mg omeprazole)
DRUG	Naproxen 500 mg tablets (PN 200 minus omeprazole)

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2006-08-22
• Last updated: 2008-04-22

Locations

1 site across 1 country: United States