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NCT04107051 Clinical Trial

Post-Marketing Surveillance Study of Nalmefene Hydrochloride Hydrate in Patients With Alcohol Dependence

Alcohol Dependence Clinical Trial

Official title:
Nalmefene Hydrochloride Hydrate Tablets 10mg Specified Drug-use Results Survey (the Safety and the Prognosis After Achieving Reduced Alcohol Intake)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04107051
Other study ID # 339-101-00015
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date March 31, 2024

Study information
Verified date March 2023
Source Otsuka Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 533
Est. completion date March 31, 2024
Est. primary completion date February 7, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Nalmefene Hydrochloride Hydrate
Oral administration of nalmefene hydrochloride hydrate

Locations
Country Name City State
Japan Otsuka Pharmaceutical Co., Ltd. Osaka

Sponsors (1)
Lead Sponsor Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Alcohol Use Disorders Identification Test-Consumption(AUDIT-C) 1 year
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