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A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-parallel-group Comparison Trial to Investigate the Effect of Nalmefene on Alcohol Consumption Reduction in Patients With Alcohol Dependence (Phase 3 Trial)

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Trial Profile

A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-parallel-group Comparison Trial to Investigate the Effect of Nalmefene on Alcohol Consumption Reduction in Patients With Alcohol Dependence (Phase 3 Trial)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Dec 2021

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At a glance

  • Drugs Nalmefene (Primary)
  • Indications Alcoholism
  • Focus Registrational; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical

Most Recent Events

  • 02 May 2020 Results published in the Psychiatry and Clinical Neurosciences
  • 08 Jan 2019 According to an Otsuka Pharmaceutical media release, the company has received regulatory approval in Japan for the manufacture and sale of Selincro Tablets 10 mg (nalmefene hydrochloride), as a treatment to reduce alcohol consumption in alcohol-dependent patients.
  • 17 Oct 2017 Primary endpoint has been met. (Change in the number of Heavy Drinking Days (HDDs) from baseline), according to an Otsuka Pharmaceutical media release.

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