Status:
COMPLETED
Post-Marketing Surveillance Study of Nalmefene Hydrochloride Hydrate in Patients with Alcohol Dependence
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Alcohol Dependence
Eligibility:
All Genders
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 ...
Eligibility Criteria
Inclusion
- 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
- Patients who has ever been treated with nalmefene hydrochloride hydrate
- Patients who are contraindicated
Key Trial Info
Start Date :
October 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 6 2024
Estimated Enrollment :
533 Patients enrolled
Trial Details
Trial ID
NCT04107051
Start Date
October 1 2019
End Date
February 6 2024
Last Update
March 21 2025
Active Locations (1)
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1
Otsuka Pharmaceutical Co., Ltd.
Osaka, Japan