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
• Trial end date: 2016-07-30

Summary

The efficacy, safety, and dose-response of nalmefene hydrochloride at 10 mg and 20 mg in patients with alcohol dependence will be evaluated in a multicenter, randomized, double-blind, placebo-controlled, 3-parallel-group comparative trial. The superiority of nalmefene hydrochloride at 20 mg to placebo will be verified in terms of reduction of alcohol consumption.

• Phase: Phase 3

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Collaborator: H. Lundbeck A/S
• Treatments: Nalmefene; Naltrexone