A Randomized Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study to Evaluate the Long-term Safety of Naldemedine for the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy

Trial Profile

A Randomized Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study to Evaluate the Long-term Safety of Naldemedine for the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Nov 2017

At a glance

  • Drugs Naldemedine (Primary)
  • Indications Constipation
  • Focus Adverse reactions; Registrational
  • Acronyms COMPOSE III
  • Sponsors Shionogi
  • Most Recent Events

    • 01 Nov 2017 Results presented at the 25th United European Gastroenterology Week
    • 01 Nov 2017 Results of pooled data from COMPOSE I, COMPOSE II and COMPOSE III studies assessing overall satisfaction and quality of life, presented at the 25th United European Gastroenterology Week.
    • 12 Oct 2017 According to a Shionogi Pharma media release, the FDA approval of naldemedine (Symproic) was based on data from the global Phase 3 COMPOSE clinical trial program, which enrolled 2346 patients with OIC and chronic non-cancer pain, comprising COMPOSE 1, COMPOSE 2 and COMPOSE 3 studies.
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