NCT06545916已完成2 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Evaluate Impact of Sunobinop (V117957) on Alcohol Consumption in Subjects Diagnosed With Moderate to Severe Alcohol Use Disorder and Seeking Treatment
Knoa Pharma LLC13 个研究点 分布在 2 个国家目标入组 209 人开始时间: 2024年10月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 209
- 试验地点
- 13
- 主要终点
- Percent heavy drinking days (HDD)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol consumption in subjects with alcohol use disorder.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Male and female age ≥18 years.
- •Diagnosis of moderate or severe alcohol use disorder.
- •Currently seeking treatment for alcohol use disorder.
- •Has 4 or more heavy drinking days (HDD) in each of the 4 weeks prior to baseline visit.
排除标准
- •Subjects that meet current DSM-5 criteria for moderate or severe substance use disorder other than alcohol and nicotine.
- •Other protocol-specific inclusion and exclusion criteria may apply.
研究组 & 干预措施
Placebo to match sunobinop
Placebo Comparator
干预措施: Placebo to match sunobinop (Drug)
Sunobinop
Experimental
干预措施: Sunobinop (Drug)
结局指标
主要结局
Percent heavy drinking days (HDD)
时间窗: Day 57
次要结局
- Number of standard unit drinks(Day 57)
- Percent of drinking days (PDD)(Day 57)
研究者
研究点 (13)
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