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A 6-month, randomized, double-blind, parallel-group, controlled, multi-center study to evaluate the incidence of gastric ulcers with PN 400 (esomeprazole/Naproxen) versus diclofenac/misoprostol in subjects who are at high risk for developing NSAID [non steroidal anti-inflammatory drugs]-associated ulcers.

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A 6-month, randomized, double-blind, parallel-group, controlled, multi-center study to evaluate the incidence of gastric ulcers with PN 400 (esomeprazole/Naproxen) versus diclofenac/misoprostol in subjects who are at high risk for developing NSAID [non steroidal anti-inflammatory drugs]-associated ulcers.

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 28 Sep 2010

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At a glance

  • Drugs Esomeprazole/naproxen (Primary) ; Diclofenac/misoprostol
  • Indications Ankylosing spondylitis; NSAID-induced ulcer; Osteoarthritis; Rheumatoid arthritis
  • Focus Adverse reactions
  • Sponsors POZEN

    • Most Recent Events

    • 28 May 2008 Status change from recruiting to discontinued, according to clinicaltrials.gov.
    • 31 Jan 2008 New trial record.

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