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A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of naldemedine in cancer patients with opioid-induced constipation

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Trial Profile

A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of naldemedine in cancer patients with opioid-induced constipation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Mar 2019

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At a glance

  • Drugs Naldemedine (Primary)
  • Indications Constipation
  • Focus Registrational; Therapeutic Use
  • Acronyms COMPOSE IV
  • Sponsors Shionogi

Most Recent Events

  • 22 Feb 2019 According to a Shionogi media release, European Commission (EC) granted a Marketing Authorisation (MA) for Rizmoic (naldemedine), for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative, based on data from three phase 3 efficacy and safety studies (V9231, V9232 and V9236) and one long term safety study (V9235).
  • 18 Dec 2018 According to a Shionogi media release, based on data from three phase 3 efficacy and safety studies (V9231, V9232 and V9236) and one long term safety study (V9235), the CHMP has adopted a positive opinion recommending Rizmoic (naldemedine), for the treatment of opioid induced constipation (OIC) in adult patients who have previously been treated with a laxative. The EC will issue a decision in due course for naldemedine, taking into account the recommendation from the CHMP.
  • 02 Oct 2017 Results published in the Journal of Clinical Oncology

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