A Phase II Multicenter, Randomized, Double-Blind, Two-Stage Clinical Trial to Evaluate the Efficacy and Safety of MK0594 in Patients With Alcohol Dependence
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 162
- 主要终点
- no heavy alcohol drinking and safety as measured by adverse experiences, laboratory safety test, vital signs, ECG, and physical examination
研究概览
简要总结
A study in patients with alcohol dependence to see if MK0594 is safe and effective in maintaining absence of heavy drinking over a 12-week treatment period.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision diagnosis of alcohol dependence and alcohol addiction
- •Patient has two heavy drinking days in the last 30 days
- •Patient has 3 days of abstinence from alcohol right before taking study medication
- •Patient has lived in the same residence for the last 2 months
排除标准
- •If female, patient is pregnant or breastfeeding
- •Patient anticipated inpatient alcohol treatment
- •Patient has a history of suicide attempt in the last year
- •Patient has schizophrenia or bipolar disorder
- •Patient has a history of multiple or serious allergies
- •Patient has participated in a clinical trial in the last 30 days
研究组 & 干预措施
Stage II, Arm 4
Placebo
干预措施: Comparator: Placebo to MK0594 (Drug)
Stage I, Arm 1
MK0594 5 mg/day
干预措施: Comparator: MK0594 5 mg/day (Drug)
Stage I, Arm 2
Placebo
干预措施: Comparator: Placebo to MK0594 (Drug)
Stage II, Arm 2
MK0594 1 mg/day
干预措施: Comparator: MK0594 1 mg/day (Drug)
Stage II, Arm 3
MK0594 1 mg/week
干预措施: Comparator: MK0594 1 mg/week (Drug)
结局指标
主要结局
no heavy alcohol drinking and safety as measured by adverse experiences, laboratory safety test, vital signs, ECG, and physical examination
时间窗: week 3 and 12 after starting study medication for efficacy and over 12 weeks and 52 weeks for safety
no heavy alcohol drinking and safety as measured by adverse experiences, laboratory safety test, vital signs, ECG, and physical examination
次要结局
- no alcohol drinking(week 3 to 12 after starting study medication and over 52 weeks)