Overview

This trial is active, not recruiting.

Condition alcohol dependence
Treatments nalmefene hydrochloride, placebo
Phase phase 3
Sponsor Otsuka Pharmaceutical Co., Ltd.
Collaborator H. Lundbeck A/S
Start date December 2014
End date August 2017
Trial size 660 participants
Trial identifier NCT02364947, 339-14-001, JapicCTI-152804

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
As-needed; tablets, orall
nalmefene hydrochloride
As-needed; tablets, orally
(Experimental)
As-needed; tablets, orall
nalmefene hydrochloride
As-needed; tablets, orally
(Placebo Comparator)
AS-needed; tablets, orall
placebo
As-needed; tablets, orally

Primary Outcomes

Measure
Change in the number of Heavy Drinking Days (HDDs) from baseline
time frame: Baseline (-2 weeks), 0, 1, 2, 4, 8, 12, 16, 20, and 24 weeks

Secondary Outcomes

Measure
Change in Total Alcohol Consumption (TAC) from baseline
time frame: Baseline (-2 weeks), 0, 1, 2, 4, 8, 12, 16, 20, and 24 weeks

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Japanese males and females aged 20 or above who have signed the informed consent form - The patient has alcohol dependence, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) and confirmed by Mini-international Neuropsychiatric Interview (M. I. N. I.) Exclusion Criteria: - The patient with a current diagnosis or history of substance use disorders (except for alcohol, nicotine, and caffeine), according to DSM-IV-TR and confirmed by M. I. N. I. - The patient has reported current use of, or has tested positive for, drugs of abuse (opiates, methadone, cocaine, amphetamines, barbiturates) at the screening test

Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Otsuka Pharmaceutical Co., Ltd..