Post-Marketing Surveillance Study of Nalmefene Hydrochlor... | NCT04107051

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

NCT04107051

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Mar 21, 2025Actual

Enrollment

533Actual

Phase

Not provided

Conditions

Alcohol Dependence

Interventions

Nalmefene Hydrochloride Hydrate

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2019Actual

Primary Completion Date

Feb 7, 2023Actual

Completion Date

Feb 6, 2024Actual

First Submitted Date

Sep 24, 2019

First Submission Date that Met QC Criteria

Sep 25, 2019

First Posted Date

Sep 27, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2025

Last Update Posted Date

Mar 21, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

533Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nalmefene Hydrochloride Hydrate	Drug	Oral administration of nalmefene hydrochloride hydrate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Alcohol Use Disorders Identification Test-Consumption(AUDIT-C)		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with alcohol dependence who are planned to be newly started on nalmefene hydrochloride hydrate for the treatment of reduction of alcohol consumption.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yasuhiko Fukuta, PhD	Otsuka Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Otsuka Pharmaceutical Co., Ltd.		Osaka			Japan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000437	Alcoholism

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided