At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 678 enrolled
Drug / intervention
Nalmefene hydrochloride +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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1 article- Ollin nets $330M to run Phase 3 trials of Vabysmo challenger from ChinaEndpoints News·2026-06-24
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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)
In Brief
A Phase 3 clinical trial evaluating Nalmefene hydrochloride and Placebo for Alcohol Dependence. Completed, enrolled 678 participants across 7 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Dependence
CountriesJapan
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartFeb 2015
First PostedFeb 2015
Primary CompletionJul 2016
TodayJul 2026
First PostedFeb 18, 2015
Enrollment StartFeb 9, 2015
Primary CompletionJul 30, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.4 years ago
Interventions
Nalmefene hydrochloridedrug
As-needed; tablets, orally
Placebodrug
As-needed; tablets, orally