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

  • End date
    Mar 31, 2024
  • participants needed
  • sponsor
    Otsuka Pharmaceutical Co., Ltd.
Updated on 4 March 2021
Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd.
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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 Alcohol abuse, Alcohol Use Disorder, Alcohol Dependence, alcoholism, alcohol dependence syndrome, chronic alcoholism
Treatment Nalmefene Hydrochloride Hydrate
Clinical Study IdentifierNCT04107051
SponsorOtsuka Pharmaceutical Co., Ltd.
Last Modified on4 March 2021


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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