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A phase III, multicentre, randomised, double-blind, parallel-group, comparative efficacy and safety study of D961H (20 mg once daily) versus placebo for the prevention of gastric and/or duodenal ulcers associated with daily nonsteroidal anti-inflammatory drug (NSAID) use

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Trial Profile

A phase III, multicentre, randomised, double-blind, parallel-group, comparative efficacy and safety study of D961H (20 mg once daily) versus placebo for the prevention of gastric and/or duodenal ulcers associated with daily nonsteroidal anti-inflammatory drug (NSAID) use

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jun 2018

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At a glance

  • Drugs Esomeprazole (Primary)
  • Indications NSAID-induced ulcer
  • Focus Therapeutic Use
  • Sponsors AstraZeneca
  • Most Recent Events

    • 26 Oct 2011 Primary endpoint 'Kaplan-Meier-event-free-survival-rate' has been met according to results presented at the 19th United European Gastroenterology Week.
    • 26 Oct 2011 Results presented at the 19th United European Gastroenterology Week.
    • 10 May 2010 Actual patient number (343) added as reported by ClinicalTrials.gov.

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