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)

Otsuka

Status and phase

Completed

Phase 3

Conditions

Alcohol Dependence

Treatments

Drug: Nalmefene hydrochloride

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02364947

JapicCTI-152804 (Other Identifier)

339-14-001

Details and patient eligibility

About

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.

Enrollment

678 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.)
The patient has a drinking risk level of High or above (> 60 g for men and > 40 g for women) both at the Screening Visit and at the Randomization Visit .

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