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

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ClinicalTrials.gov Identifier: NCT04107051
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Description
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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
Alcohol Dependence Drug: Nalmefene Hydrochloride Hydrate

Study Design
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Study Type : Observational
Estimated Enrollment : 350 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 : October 1, 2019
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: Nalmefene Hydrochloride Hydrate
    Oral administration of nalmefene hydrochloride hydrate

Outcome Measures
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Primary Outcome Measures :
  1. Alcohol Use Disorders Identification Test-Consumption(AUDIT-C) [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04107051


Contacts
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Contact: Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd. +81-6-6943-7722 komaniwa.satoshi@otsuka.jp

Locations
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Japan
Otsuka Pharmaceutical Co., Ltd. Recruiting
Osaka, Japan
Contact: Pharmacovigilance Department         
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Yasuhiko Fukuta, PhD Otsuka Pharmaceutical Co., Ltd.
More Information
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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04107051    
Other Study ID Numbers: 339-101-00015
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
 Nalmefene
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents