Clinical 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Dependence
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2015-02-18
Enrollment: 678
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24
timeFrame: Week 24
measure: Change in Total Alcohol Consumption (TAC) From Baseline at Week 12
timeFrame: Week 12
measure: Change in Total Alcohol Consumption (TAC) From Baseline at Week 24
timeFrame: Week 24
measure: Response Shift Drinking Risk Level (RSDRL) at Week 12
timeFrame: Week 12
measure: Response Shift Drinking Risk Level (RSDRL) at Week 24
timeFrame: Week 24
measure: Response Low Drinking Risk Level (RLDRL) at Week 12
timeFrame: Week 12
measure: Response Low Drinking Risk Level (RLDRL) at Week 24
timeFrame: Week 24
measure: 70% TAC Responder Rate at Week 12
timeFrame: Week 12
measure: 70% TAC Responder Rate at Week 24
timeFrame: Week 24
measure: HDD Responder Rate at Week 12
timeFrame: Week 12
measure: HDD Responder Rate at Week 24
timeFrame: Week 24
measure: Change in CGI-S From Baseline at Week 12
timeFrame: Week 12
measure: Change in CGI-S From Baseline at Week 24
timeFrame: Week 24
measure: Change in CGI-I From Baseline at Week 12
timeFrame: Week 12
measure: Change in CGI-I From Baseline at Week 24
timeFrame: Week 24
measure: Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 12
timeFrame: Week 12
measure: Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 24
timeFrame: Week 24
measure: Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 12
timeFrame: Week 12
measure: Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 24
timeFrame: Week 24
Other outcomes:
Locations:
city: Region
country: Japan
facility: Chubu
city: Region
country: Japan
facility: Hokkaido
city: Region
country: Japan
facility: Kanto
city: Region
country: Japan
facility: Kinki
city: Region
country: Japan
facility: Kyusyu
city: Region
country: Japan
facility: Tohoku
city: Region
country: Japan
facility: Tyugoku
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Osamu Sato
role: STUDY_DIRECTOR
References: