A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
- Registration Number
- NCT02382276
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 405
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nalmefene hydrochloride 20 mg Nalmefene hydrochloride As-needed; tablets, orally
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events 24-week treatment period
- Secondary Outcome Measures
Name Time Method Change in Total Alcohol Consumption (TAC) From Baseline Week 24 Change in the Number of Heavy Drinking Days (HDDs) From Baseline Week 24
Trial Locations
- Locations (7)
Kinki
🇯🇵Region, Japan
Hokkaido
🇯🇵Region, Japan
Chubu
🇯🇵Region, Japan
Kyusyu
🇯🇵Region, Japan
Tohoku
🇯🇵Region, Japan
Tyugoku
🇯🇵Region, Japan
Kanto
🇯🇵Region, Japan