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: 02 Jun 2017

At a glance

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

    • 19 Apr 2017 Status changed from active, no longer recruiting to completed.
    • 08 Apr 2017 This trial has been completed in Portugal (end date: 2016-01-12), according to the European Clinical Trials Database
    • 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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