A phase 3, multicenter, open-label study of naldemedine in cancer patients with opioid-induced constipation - extension study

Trial Profile

A phase 3, multicenter, open-label study of naldemedine in cancer patients with opioid-induced constipation - extension study

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Oct 2017

At a glance

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

    • 02 Oct 2017 Results published in the Journal of Clinical Oncology
    • 07 Jun 2016 Results presented at the 52nd Annual Meeting of the American Society of Clinical Oncology
    • 06 Jun 2016 According to a Shionogi media release, the New Drug Application (NDA) submitted in the U.S. for naldemedine, a once-daily, oral 0.2 mg tablet, has been accepted for review and the target action date under the Prescription Drug User Fee Act (PDUFA) is March 23, 2017.
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