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A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction

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Trial Profile

A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Dec 2021

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At a glance

  • Drugs Lubiprostone (Primary)
  • Indications Constipation
  • Focus Registrational; Therapeutic Use
  • Sponsors Sucampo Pharmaceuticals

    • Most Recent Events

    • 28 Aug 2017 Results of post-hoc pooled analysis of this and other 5 studies published in the Digestive Diseases and Sciences.
    • 28 Apr 2015 Results published in the American Journal of Gastroenterology.
    • 23 Apr 2013 FDA approved sNDA for lubiprostone for opioid-induced constipation in adults with chronic, non-cancer pain based on results of OPAL trials and a long-term safety study, according to a media release from Sucampo Pharmaceuticals and Takeda Pharmaceuticals.

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