Nalmefene Efficacy Study II: Randomised, Double-blind, Placebo-controlled, Parallel-group, Efficacy Study of 20 mg Nalmefene, as Needed Use, in Patients With Alcohol Dependence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 678
- 试验地点
- 57
- 主要终点
- Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)
研究概览
简要总结
The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.
详细描述
Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. Excessive intake of alcohol reduces the life span by a decade, and alcohol drinking is strongly related to mortality from liver cirrhosis, chronic pancreatitis, certain cancers, hypertension, accidents and violence. This study is planned to evaluate the efficacy and safety of as needed use of nalmefene 18.06 mg versus placebo in decreasing monthly Heavy Drinking Days (HDDs) and decreasing the total consumption during a period of 24 weeks in adult patients with alcohol dependence.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In- and outpatients who:
- •had a primary diagnosis of alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - text revision (DSM-IV-TR) criteria
- •had had ≥6 HDDs in the 4 weeks preceding the Screening Visit
- •had had an average alcohol consumption at WHO medium risk level or above in the 4 weeks preceding the Screening Visit
排除标准
- •The patient:
- •had a DSM-IV Axis I disorder other than alcohol dependence or nicotine dependence
- •had an antisocial personality disorder
- •had risk of suicide evaluated by the suicidality module of the Mini-International Neuropsychiatric Interview (MINI)
- •had a history of delirium tremens or alcohol withdrawal seizures
- •reported current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists
- •reported current or recent treatment with antipsychotics or antidepressants
- •was pregnant or breast-feeding
- •Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Nalmefene
干预措施: Nalmefene (Drug)
结局指标
主要结局
Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)
时间窗: Baseline and Month 6
Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.
Change From Baseline in the Monthly Total Alcohol Consumption (TAC)
时间窗: Baseline and Month 6
TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).
次要结局
- Change From Baseline in Clinical Status Using CGI-S(Baseline and Week 24)
- Drinking Risk Level (RSDRL) Response(Month 6)
- Change in Clinical Status Using the CGI-I(Week 24)
- Liver Function Test Gamma-glutamyl Transferase (GGT)(Week 24)
- Liver Function Test Alanine Aminotransferase (ALAT)(Week 24)