Post-Marketing Surveillance Study of Nalmefene Hydrochloride Hydrate in Patients with Alcohol Dependence
Completed
- Conditions
- Alcohol Dependence
- Registration Number
- NCT04107051
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
The purpose of this study is to investigate the safety and the prognosis after achieving reduced alcohol intake in patients with alcohol dependence who received treatment for the reduction of alcohol intake in the routine clinical setting in Japan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 533
Inclusion Criteria
- Clinical diagnosis of Alcohol Dependence
- Must agree to follow-up during the first year of prescription and publication of survey results
- Patients whose goal of treatment for Alcohol Dependence is to reduce alcohol consumption
- Patients receiving psychosocial treatment aiming to promote treatment adherence and reduction of alcohol consumption
- Patients who have chronic heavy drinking
- Patients who have confirmed that they are willing to receive treatment to reduce their alcohol consumption
Exclusion Criteria
- Patients who has ever been treated with nalmefene hydrochloride hydrate
- Patients who are contraindicated
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Alcohol Use Disorders Identification Test-Consumption(AUDIT-C) 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Otsuka Pharmaceutical Co., Ltd.
🇯🇵Osaka, Japan