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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date September 24, 2019
First Posted Date September 27, 2019
Last Update Posted Date February 21, 2021
Actual Study Start Date October 1, 2019
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 25, 2019)		 Alcohol Use Disorders Identification Test-Consumption(AUDIT-C) [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post-Marketing Surveillance Study of Nalmefene Hydrochloride Hydrate in Patients With Alcohol Dependence
Official Title Nalmefene Hydrochloride Hydrate Tablets 10mg Specified Drug-use Results Survey (the Safety and the Prognosis After Achieving Reduced Alcohol Intake)
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Alcohol Dependence
Intervention Drug: Nalmefene Hydrochloride Hydrate
Oral administration of nalmefene hydrochloride hydrate
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 25, 2019)		 350
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2024
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd. +81-6-6943-7722 komaniwa.satoshi@otsuka.jp
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT04107051
Other Study ID Numbers 339-101-00015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Otsuka Pharmaceutical Co., Ltd.
Study Sponsor Otsuka Pharmaceutical Co., Ltd.
Collaborators Not Provided
Investigators
Study Director: Yasuhiko Fukuta, PhD Otsuka Pharmaceutical Co., Ltd.
PRS Account Otsuka Pharmaceutical Co., Ltd.
Verification Date February 2021