Official Title: “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 400 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers”

This study uses a randomized, double-blind, controlled design and will be conducted in approximately 60 sites aiming to enroll a total number of 400 subjects (200 per arm). A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed, or the endpoint has been reached: gastric ulcer confirmed by endoscopy.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2008

Objectives:

Primary: To demonstrate that PN 400 is effective in reducing the risk of gastric ulcers in subjects at risk for developing NSAID-associated gastric ulcers.

Secondary: - To determine if PN 400 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 PN 400 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 PN 400 versus naproxen - To evaluate the safety and tolerability of PN 400 and naproxen

Intervention(s) in this Clinical Trial

• Drug: PN400
  • PN 400 tablets (naproxen 500 mg and esomeprazole 20 mg) bid taken orally.
• Drug: naproxen
  • naproxen bid

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • PN 400 twice daily (bid)
• Active Comparator: 2
  • naproxen

Primary Measures

• A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed, or the endpoint has been reached: gastric ulcer confirmed by endoscopy.
  • Time Frame: 6 months
    Safety Issue?: No

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pozen

Overall Clinical Trial Officials and Contacts

David Taylor Study Director Pozen  

Information obtained from ClinicalTrials.gov on August 08, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00527787

Study ID Number: PN400-301 & 302

ClinicalTrials.gov Identifier: NCT00527787

Health Authority: United States: Food and Drug Administration