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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Dec 2023

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At a glance

  • Drugs Alvimopan (Primary)
  • Indications Constipation; Intestinal disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Cubist Pharmaceuticals; GlaxoSmithKline; GSK

Most Recent Events

  • 01 Feb 2011 Primary endpoint 'Complete-spontaneous-bowel-movement' has not been met.
  • 01 Feb 2011 Primary endpoint 'Clinical-response-rate' has not been met.
  • 01 Feb 2011 Results published in the Journal of Pain.

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