JPRN-jRCT2080222752已完成3 期
A multicenter, randomized, double-blind, placebo-controlled, 3-parallel-group comparison trial to investigate the effect of nalmefene on alcohol consumption reduction in patients with alcohol dependence (phase 3 trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 678
研究概览
简要总结
The results of this trial demonstrated the efficacy of nalmefene hydrochloride 20 mg and 10 mg in reducing alcohol consumption in patients with alcohol dependence, with good tolerability and no notable safety concerns.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Japanese males and females aged 20 or above who have signed the informed consent form.
- •- The patient has alcohol dependence, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-4-TR) and confirmed by Mini-international Neuropsychiatric Interview (M.I.N.I.).
排除标准
- •- The patient with a current diagnosis or history of substance use disorders (except for alcohol, nicotine, and caffeine), according to DSM-4-TR and confirmed by M.I.N.I..
- •- The patient has reported current use of, or has tested positive for, drugs of abuse (opiates, methadone, cocaine, amphetamines, barbiturates) at the screening test.
研究者
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