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

• Sponsor: Otsuka Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04107051
• Collaborator: (none)
• Enrollment: 533
• Location: 1
• Anticipated Duration (Months): 54
• Patients Per Site Per Month: 9.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Dependence	Drug: Nalmefene Hydrochloride Hydrate

Study Design

• Study Type: Observational
• Actual Enrollment: 533 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Nalmefene Hydrochloride Hydrate Tablets 10mg Specified Drug-use Results Survey (the Safety and the Prognosis After Achieving Reduced Alcohol Intake)
• Actual Study Start Date: Oct 1, 2019
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: Mar 31, 2024

Outcome Measures

Primary Outcome Measures

1. Alcohol Use Disorders Identification Test-Consumption(AUDIT-C) [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Otsuka Pharmaceutical Co., Ltd.	Osaka		Japan

Sponsors and Collaborators

• Otsuka Pharmaceutical Co., Ltd.

Investigators

• Study Director: Yasuhiko Fukuta, PhD, Otsuka Pharmaceutical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Otsuka Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04107051
• Other Study ID Numbers: 339-101-00015
• First Posted: Sep 27, 2019
• Last Update Posted: Apr 7, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alcoholism; Nalmefene

Study Results

No Results Posted as of Apr 7, 2022