A Randomized, Double-Blind, Phase 3 Study of the Efficacy and Safety of HZT-501 in Subjects Requiring NSAID Treatment.

Trial Profile

A Randomized, Double-Blind, Phase 3 Study of the Efficacy and Safety of HZT-501 in Subjects Requiring NSAID Treatment.

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Dec 2014

At a glance

  • Drugs Ibuprofen/famotidine (Primary) ; Ibuprofen
  • Indications Back pain; Musculoskeletal pain; NSAID-induced ulcer; Osteoarthritis; Rheumatoid arthritis
  • Focus Adverse reactions; Registrational
  • Acronyms REDUCE-2
  • Sponsors Horizon Pharma
  • Most Recent Events

    • 20 Dec 2011 Results from a pooled analysis (REDUCE-1 and REDUCE-2) published in the American Journal of Gastroenterology.
    • 25 Apr 2011 Based on the results of this and the REDUCE-1 trial, the US FDA approved ibuprofen/famotidine for the reduction of the risk of development of upper gastrointestinal ulcers in patients with rheumatoid arthritis or osteoarthritis.
    • 03 Nov 2010 Results will be presented at the 74th Annual Scientific Meeting of the American College of Rheumatology and the 45th Annual Meeting of the Association of Rheumatology and Health Professionals, according to an Horizon Pharma media release.
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