A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Naldemedine in 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 Study of Naldemedine in 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: 12 Oct 2017

At a glance

  • Drugs Naldemedine (Primary)
  • Indications Constipation
  • Focus Registrational; Therapeutic Use
  • Acronyms COMPOSE I; COMPOSE-1
  • Sponsors Shionogi
  • Most Recent Events

    • 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.
    • 06 Sep 2017 According to a Purdue Pharma media release, Purdue Pharma L.P. and Shionogi Inc. will present results data from thee studies (COMPOSE 1, 2 and 3) at the 11th Annual PAINWeek Conference
    • 23 Mar 2017 According to a Shionogi media release, the company has announced that the U.S. Food and Drug Administration (FDA) approved Symproic (naldemedine) 0.2 mg tablets C-II as a once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
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