A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Safety, Tolerability and Efficacy Study of 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
- 665
- 试验地点
- 60
- 主要终点
- Number of Patients With Adverse Events (AEs)
研究概览
简要总结
The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in patients with 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 long-term safety and tolerability as well as to evaluate the efficacy of as needed use of 18.06 mg nalmefene in 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 Heavy Drinking Days (HDDs) in the 4 weeks preceding the Screening Visit
排除标准
- •The patient:
- •had a severe psychiatric disorder or 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
- •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
Number of Patients With Adverse Events (AEs)
时间窗: Serious Adverse Events: 52 weeks and a safety follow-up (visit/telephone call) scheduled for 4 weeks after completion of the study or after withdrawal from the study. Other Adverse Events: 52 weeks.
Overview of AEs
Percentage of Patients Who Withdrew Due to Intolerance to Treatment
时间窗: Baseline to Week 52
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
- Drinking Risk Level (RSDRL) Response(Month 13)
- Change From Baseline in Clinical Status Using CGI-S(Baseline and Week 52)
- Change in Clinical Status Using the CGI-I(Week 52)
- Liver Function Test Gamma-glutamyl Transferase (GGT)(Week 52)
- Liver Function Test Alanine Aminotransferase (ALAT)(Week 52)
- Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)(Baseline and Month 13)
- Change From Baseline in the Monthly Total Alcohol Consumption (TAC)(Baseline and Month 13)