A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD)

Trial Profile

A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD)

Completed
Phase of Trial: Phase III

Latest Information Update: 15 Feb 2016

At a glance

  • Drugs Lubiprostone (Primary)
  • Indications Constipation
  • Focus Registrational; Therapeutic Use
  • Acronyms OPAL
  • Most Recent Events

    • 01 May 2013 OPAL is a trial programme, please do not add it as an acronym.
    • 01 May 2013 New trial record
    • 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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