NCT02364947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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 678
- 试验地点
- 7
- 主要终点
- Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12
研究概览
简要总结
The efficacy, safety, and dose-response of nalmefene hydrochloride at 10 mg and 20 mg in patients with alcohol dependence will be evaluated in a multicenter, randomized, double-blind, placebo-controlled, 3-parallel-group comparative trial. The superiority of nalmefene hydrochloride at 20 mg to placebo will be verified in terms of reduction of alcohol consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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-IV-TR) and confirmed by Mini-international Neuropsychiatric Interview (M. I. N. I.)
- •The patient has a drinking risk level of High or above (> 60 g for men and > 40 g for women) both at the Screening Visit and at the Randomization Visit .
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-IV-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
研究组 & 干预措施
Nalmefene hydrochloride 10 mg
Experimental
干预措施: Nalmefene hydrochloride (Drug)
Nalmefene hydrochloride 20 mg
Experimental
干预措施: Nalmefene hydrochloride (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12
时间窗: Week 12
The number of HDDs is defined as the number of days per month \[days/month\] with alcohol consumption of \> 60 g for males and \> 40 g for females
次要结局
- HDD Responder Rate at Week 24(Week 24)
- Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24(Week 24)
- Change in Total Alcohol Consumption (TAC) From Baseline at Week 12(Week 12)
- Change in Total Alcohol Consumption (TAC) From Baseline at Week 24(Week 24)
- Response Shift Drinking Risk Level (RSDRL) at Week 12(Week 12)
- Response Low Drinking Risk Level (RLDRL) at Week 12(Week 12)
- Response Low Drinking Risk Level (RLDRL) at Week 24(Week 24)
- 70% TAC Responder Rate at Week 12(Week 12)
- 70% TAC Responder Rate at Week 24(Week 24)
- HDD Responder Rate at Week 12(Week 12)
- Response Shift Drinking Risk Level (RSDRL) at Week 24(Week 24)
- Change in CGI-S From Baseline at Week 12(Week 12)
- Change in CGI-S From Baseline at Week 24(Week 24)
- Change in CGI-I From Baseline at Week 12(Week 12)
- Change in CGI-I From Baseline at Week 24(Week 24)
- Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 12(Week 12)
- Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 24(Week 24)
- Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 12(Week 12)
- Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 24(Week 24)
研究者
研究点 (7)
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