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)

Alcohol Dependence Clinical 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364947
• Other study ID #: 339-14-001
• Secondary ID: JapicCTI-152804
• Status: Completed
• Phase: Phase 3
• Start date: February 9, 2015
• Est. completion date: July 30, 2016

Study information

• Verified date: July 2019
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 678
• Est. completion date: July 30, 2016
• Est. primary completion date: July 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcohol Drinking
• Alcoholism

Intervention

Drug:
• Nalmefene hydrochloride
As-needed; tablets, orally
• Placebo
As-needed; tablets, orally

Locations

Country	Name	City	State
Japan	Chubu	Region
Japan	Hokkaido	Region
Japan	Kanto	Region
Japan	Kinki	Region
Japan	Kyusyu	Region
Japan	Tohoku	Region
Japan	Tyugoku	Region

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.	H. Lundbeck A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Number of Heavy Drinking Days (HDDs) From Baseline at 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	Week 12
Secondary	Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24		Week 24
Secondary	Change in Total Alcohol Consumption (TAC) From Baseline at Week 12		Week 12
Secondary	Change in Total Alcohol Consumption (TAC) From Baseline at Week 24		Week 24
Secondary	Response Shift Drinking Risk Level (RSDRL) at Week 12	Proportion of patients with a downward shift in drinking risk level of two categories or more	Week 12
Secondary	Response Shift Drinking Risk Level (RSDRL) at Week 24	Proportion of patients with a downward shift in drinking risk level of two categories or more	Week 24
Secondary	Response Low Drinking Risk Level (RLDRL) at Week 12	Proportion of patients with low or lower drinking risk level	Week 12
Secondary	Response Low Drinking Risk Level (RLDRL) at Week 24	Proportion of patients with low or lower drinking risk level	Week 24
Secondary	70% TAC Responder Rate at Week 12	Proportion of patients with a 70% decrease in TAC	Week 12
Secondary	70% TAC Responder Rate at Week 24	Proportion of patients with a 70% decrease in TAC	Week 24
Secondary	HDD Responder Rate at Week 12	Proportion of patients with =4 HDDs	Week 12
Secondary	HDD Responder Rate at Week 24	Proportion of patients with =4 HDDs	Week 24
Secondary	Change in CGI-S From Baseline at Week 12	The CGI-S scale was used by clinicians when assessing their global impression of a patient's current clinical condition. The investigator or subinvestigator used his/her clinical experience with this patient population to rate the severity of a subject's clinical condition on a 7-point scale ranging from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients).	Week 12
Secondary	Change in CGI-S From Baseline at Week 24	The CGI-S scale was used by clinicians when assessing their global impression of a patient's current clinical condition. The investigator or subinvestigator used his/her clinical experience with this patient population to rate the severity of a subject's clinical condition on a 7-point scale ranging from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients).	Week 24
Secondary	Change in CGI-I From Baseline at Week 12	The CGI-I scale is used to assess a patient's improvement (or worsening). The investigator or subinvestigator assesses a subject's condition relative to baseline on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse).	Week 12
Secondary	Change in CGI-I From Baseline at Week 24	The CGI-I scale was used to assess a patient's improvement (or worsening). The investigator or subinvestigator assesses a subject's condition relative to baseline on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse).	Week 24
Secondary	Change in Logarithm Scale in Serum ?-glutamyltransferase From Baseline at Week 12	All-patients-randomised set	Week 12
Secondary	Change in Logarithm Scale in Serum ?-glutamyltransferase From Baseline at Week 24	All-patients-randomised set	Week 24
Secondary	Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 12	All-patients-randomised set	Week 12
Secondary	Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 24	All-patients-randomised set	Week 24