A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Nalmefene hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence
Eligibility Criteria
Inclusion Criteria:
- Patients who have completed Study 339-14-001
- Patients who have signed the informed consent form for Study 339-14-002
Exclusion Criteria:
- The patient has a clinically significant unstable illness (eg, complication of New York Heart Association (NYHA) class III or IV heart failure or angina pectoris, renal function disorder with estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73 m2, hepatic failure, and neoplastic disorder)
- The patient has a clinically significant abnormal electrocardiogram (ECG) which is inappropriate for the participation in the trial in the opinion of the investigator or subinvestigator
Sites / Locations
- Chubu
- Hokkaido
- Kanto
- Kinki
- Kyusyu
- Tohoku
- Tyugoku
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nalmefene hydrochloride 20 mg
Arm Description
As-needed; tablets, orally
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
Secondary Outcome Measures
Change in the Number of Heavy Drinking Days (HDDs) From Baseline
Change in Total Alcohol Consumption (TAC) From Baseline
Full Information
NCT ID
NCT02382276
First Posted
February 10, 2015
Last Updated
July 2, 2020
Sponsor
Otsuka Pharmaceutical Co., Ltd.
Collaborators
H. Lundbeck A/S
1. Study Identification
Unique Protocol Identification Number
NCT02382276
Brief Title
A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
Official Title
A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 13, 2015 (Actual)
Primary Completion Date
January 18, 2017 (Actual)
Study Completion Date
January 18, 2017 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
405 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nalmefene hydrochloride 20 mg
Arm Type
Experimental
Arm Description
As-needed; tablets, orally
Intervention Type
Drug
Intervention Name(s)
Nalmefene hydrochloride
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Time Frame
24-week treatment period
Secondary Outcome Measure Information:
Title
Change in the Number of Heavy Drinking Days (HDDs) From Baseline
Time Frame
Week 24
Title
Change in Total Alcohol Consumption (TAC) From Baseline
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have completed Study 339-14-001
Patients who have signed the informed consent form for Study 339-14-002
Exclusion Criteria:
The patient has a clinically significant unstable illness (eg, complication of New York Heart Association (NYHA) class III or IV heart failure or angina pectoris, renal function disorder with estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73 m2, hepatic failure, and neoplastic disorder)
The patient has a clinically significant abnormal electrocardiogram (ECG) which is inappropriate for the participation in the trial in the opinion of the investigator or subinvestigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ono Hiroaki, Mr
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 Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
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