NCT01798303已完成2 期
Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial in Patients With Alcohol Dependence
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change from Baseline to Week 8 in the Average Number of Drinks per Day (NDD) Measured Over 28 Days
研究概览
简要总结
The main purpose of this study is to evaluate a once daily (QD) 40-milligram (mg) oral dose of LY2940094 in participants with an alcohol dependency to evaluate if LY2940094 will reduce alcohol drinking in these participants. The study will last for 8 weeks.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present with alcohol dependence (AD) defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR 303.9)
- •Must have 3 to 6 heavy drinking days per week as assessed by the Timeline Follow Back (TLFB) scale at screening and baseline (heavy drinking is defined as greater than 4 drinks per day for females and greater than 5 drinks per day for males)
- •Have a body mass index (BMI) between 18 and 35 kilograms per square meter (kg/m^2)
排除标准
- •Have had prior seizures or other condition that would place the participant at increased risk of seizures, and participants taking anticonvulsants for seizure control
- •Have any other clinically significant medical condition or circumstance prior to randomization that, in the opinion of the investigator, could affect participant safety
- •Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, (DSM-IV) Axis I criteria for a lifetime diagnosis of schizophrenia, schizoaffective disorder, bipolar I disorder, or other psychoses
研究组 & 干预措施
LY2940094
Experimental
40 mg LY2940094 oral tablet, QD for 8 weeks
干预措施: LY2940094 (Drug)
Placebo
Placebo Comparator
Identically matched placebo oral tablet, QD for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline to Week 8 in the Average Number of Drinks per Day (NDD) Measured Over 28 Days
时间窗: Baseline, Week 8
次要结局
- Change from Baseline to Week 8 in Gammaglutamyl Transferase (GGT)(Baseline, Week 8)
- Percentage of Days Abstinent per Month(Baseline and Week 8)
- Percentage of Heavy Drinking Days per Month(Baseline and Week 8)
- Percentage of Participants with No (0) Heavy Drinking Days per Month(Baseline and Week 8)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study With LY293111, Gemcitabine and Placebo in Patients With Pancreatic CancerPancreatic CancerNCT00055250Eli Lilly and Company130
已完成
2 期
A Study With Gemcitabine, Cisplatin, and LY293111 in Non-Small Cell Lung CancerCarcinoma, Non-Small-Cell LungNCT00069875Eli Lilly and Company195
已完成
1 期
A Study of LY3009104(Baricitinib) for Healthy SubjectsHealthy VolunteerNCT01247350Eli Lilly and Company34
已完成
1 期
A Study of LY3549492 in Healthy ParticipantsHealthyNCT04758234Eli Lilly and Company54
已完成
1 期
A Study of Multiple Doses of LY2922470 in Participants With DiabetesDiabetes Mellitus, Type 2NCT01867216Eli Lilly and Company66