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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Feb 2019

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At a glance

  • Drugs Naldemedine (Primary)
  • Indications Constipation
  • Focus Adverse reactions; Registrational
  • Acronyms COMPOSE III
  • 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.
    • 31 Aug 2018 Biomarkers information updated
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