CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 405 enrolled
Drug / intervention
Nalmefene hydrochloridedrug
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.

Search/NCT02382276
NCT02382276Phase 3Completed
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A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Mar 6, 2015·Updated Jul 20, 2020

In Brief

A Phase 3 clinical trial evaluating Nalmefene hydrochloride for Alcohol Dependence. Completed, enrolled 405 participants across 7 sites.

Detailed Summary

The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Dependence
CountriesJapan
CollaboratorsH. Lundbeck A/S

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 6, 2015
Enrollment StartJul 13, 2015
Primary CompletionJan 18, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.3 years ago

Interventions

Nalmefene hydrochloridedrug