Back to resultsA 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)
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Nalmefene hydrochloride
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence
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
Sites / Locations
- Chubu
- Hokkaido
- Kanto
- Kinki
- Kyusyu
- Tohoku
- Tyugoku
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Nalmefene hydrochloride 10 mg
Nalmefene hydrochloride 20 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24
Change in Total Alcohol Consumption (TAC) From Baseline at Week 12
Change in Total Alcohol Consumption (TAC) From Baseline at Week 24
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
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
Response Low Drinking Risk Level (RLDRL) at Week 12
Proportion of patients with low or lower drinking risk level
Response Low Drinking Risk Level (RLDRL) at Week 24
Proportion of patients with low or lower drinking risk level
70% TAC Responder Rate at Week 12
Proportion of patients with a 70% decrease in TAC
70% TAC Responder Rate at Week 24
Proportion of patients with a 70% decrease in TAC
HDD Responder Rate at Week 12
Proportion of patients with ≤4 HDDs
HDD Responder Rate at Week 24
Proportion of patients with ≤4 HDDs
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).
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).
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).
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).
Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 12
All-patients-randomised set
Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 24
All-patients-randomised set
Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 12
All-patients-randomised set
Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 24
All-patients-randomised set
Full Information
NCT ID
NCT02364947
First Posted
February 10, 2015
Last Updated
September 3, 2019
Sponsor
Otsuka Pharmaceutical Co., Ltd.
Collaborators
H. Lundbeck A/S
1. Study Identification
Unique Protocol Identification Number
NCT02364947
Brief 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)
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 9, 2015 (Actual)
Primary Completion Date
July 30, 2016 (Actual)
Study Completion Date
July 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
Collaborators
H. Lundbeck A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
678 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nalmefene hydrochloride 10 mg
Arm Type
Experimental
Arm Title
Nalmefene hydrochloride 20 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Nalmefene hydrochloride
Intervention Description
As-needed; tablets, orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
As-needed; tablets, orally
Primary Outcome Measure Information:
Title
Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12
Description
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
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24
Time Frame
Week 24
Title
Change in Total Alcohol Consumption (TAC) From Baseline at Week 12
Time Frame
Week 12
Title
Change in Total Alcohol Consumption (TAC) From Baseline at Week 24
Time Frame
Week 24
Title
Response Shift Drinking Risk Level (RSDRL) at Week 12
Description
Proportion of patients with a downward shift in drinking risk level of two categories or more
Time Frame
Week 12
Title
Response Shift Drinking Risk Level (RSDRL) at Week 24
Description
Proportion of patients with a downward shift in drinking risk level of two categories or more
Time Frame
Week 24
Title
Response Low Drinking Risk Level (RLDRL) at Week 12
Description
Proportion of patients with low or lower drinking risk level
Time Frame
Week 12
Title
Response Low Drinking Risk Level (RLDRL) at Week 24
Description
Proportion of patients with low or lower drinking risk level
Time Frame
Week 24
Title
70% TAC Responder Rate at Week 12
Description
Proportion of patients with a 70% decrease in TAC
Time Frame
Week 12
Title
70% TAC Responder Rate at Week 24
Description
Proportion of patients with a 70% decrease in TAC
Time Frame
Week 24
Title
HDD Responder Rate at Week 12
Description
Proportion of patients with ≤4 HDDs
Time Frame
Week 12
Title
HDD Responder Rate at Week 24
Description
Proportion of patients with ≤4 HDDs
Time Frame
Week 24
Title
Change in CGI-S From Baseline at Week 12
Description
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).
Time Frame
Week 12
Title
Change in CGI-S From Baseline at Week 24
Description
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).
Time Frame
Week 24
Title
Change in CGI-I From Baseline at Week 12
Description
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).
Time Frame
Week 12
Title
Change in CGI-I From Baseline at Week 24
Description
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).
Time Frame
Week 24
Title
Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 12
Description
All-patients-randomised set
Time Frame
Week 12
Title
Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 24
Description
All-patients-randomised set
Time Frame
Week 24
Title
Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 12
Description
All-patients-randomised set
Time Frame
Week 12
Title
Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 24
Description
All-patients-randomised set
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osamu Sato
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Chubu
City
Region
Country
Japan
Facility Name
Hokkaido
City
Region
Country
Japan
Facility Name
Kanto
City
Region
Country
Japan
Facility Name
Kinki
City
Region
Country
Japan
Facility Name
Kyusyu
City
Region
Country
Japan
Facility Name
Tohoku
City
Region
Country
Japan
Facility Name
Tyugoku
City
Region
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
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)
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