NCT02364947CompletedPhase 3
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 Pharmaceutical Co., Ltd.7 sites in 1 country678 target enrollmentStarted: February 9, 2015Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 678
- Locations
- 7
- Primary Endpoint
- Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Nalmefene hydrochloride 10 mg
Experimental
Intervention: Nalmefene hydrochloride (Drug)
Nalmefene hydrochloride 20 mg
Experimental
Intervention: Nalmefene hydrochloride (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12
Time Frame: Week 12
The number of HDDs is defined as the number of days per month \[days/month\] with alcohol consumption of \> 60 g for males and \> 40 g for females
Secondary Outcomes
- HDD Responder Rate at Week 24(Week 24)
- Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24(Week 24)
- Change in Total Alcohol Consumption (TAC) From Baseline at Week 12(Week 12)
- Change in Total Alcohol Consumption (TAC) From Baseline at Week 24(Week 24)
- Response Shift Drinking Risk Level (RSDRL) at Week 12(Week 12)
- Response Low Drinking Risk Level (RLDRL) at Week 12(Week 12)
- Response Low Drinking Risk Level (RLDRL) at Week 24(Week 24)
- 70% TAC Responder Rate at Week 12(Week 12)
- 70% TAC Responder Rate at Week 24(Week 24)
- HDD Responder Rate at Week 12(Week 12)
- Response Shift Drinking Risk Level (RSDRL) at Week 24(Week 24)
- Change in CGI-S From Baseline at Week 12(Week 12)
- Change in CGI-S From Baseline at Week 24(Week 24)
- Change in CGI-I From Baseline at Week 12(Week 12)
- Change in CGI-I From Baseline at Week 24(Week 24)
- Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 12(Week 12)
- Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 24(Week 24)
- Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 12(Week 12)
- Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 24(Week 24)
Investigators
Study Sites (7)
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