drugset / Trial / NCT02364947

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)

NCT02364947

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2015-02-09
Primary completion
2016-07-30
Completion
2016-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Nalmefene Small molecule 10 mg Oral
Subject Nalmefene Small molecule 20 mg Oral

Indications