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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.

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Trial Profile

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.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Aug 2016

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At a glance

  • Drugs Esomeprazole/naproxen (Primary) ; Naproxen
  • Indications Ankylosing spondylitis; Duodenal ulcer; Gastric ulcer; Musculoskeletal pain; NSAID-induced gastric damage; NSAID-induced ulcer; Osteoarthritis; Rheumatoid arthritis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors POZEN

Most Recent Events

  • 11 Oct 2010 VIMOVO (naproxen/ esomeprazole) received positive agreement for approval, based on the results of this trial, in 23 countries across the European Union, according to an astrazeneca media release.
  • 30 Apr 2010 Exomeprazole/naproxen has been approved by the FDA according to an AstraZeneca media release. The approval was based on results from a clinical programme including results from this trial.
  • 28 Oct 2009 Key secondary endpoint results presented at the 74th Annual Scientific Meeting of the American College of Gastroenterology.

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