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临床试验/NCT04107051
NCT04107051已完成不适用

Nalmefene Hydrochloride Hydrate Tablets 10mg Specified Drug-use Results Survey (the Safety and the Prognosis After Achieving Reduced Alcohol Intake)

Otsuka Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 533 人开始时间: 2019年10月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
533
试验地点
1
主要终点
Alcohol Use Disorders Identification Test-Consumption(AUDIT-C)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients who has ever been treated with nalmefene hydrochloride hydrate
  • Patients who are contraindicated

结局指标

主要结局

Alcohol Use Disorders Identification Test-Consumption(AUDIT-C)

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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