Randomized Placebo Controlled Trial Assessing the Efficacy and Safety of BP1.4979 in Smoking Cessation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bioprojet
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- 4-week prolonged abstinence from smoking cigarettes
研究概览
简要总结
Clinical study which aim is to assess in heavy smokers willing to quit smoking the efficacy and the safety profile of BP1.4979 for smoking cessation on the total abstinence measured by subject diary and confirmed by exhaled CO (abstinent < 10 ppm).
详细描述
BP1.4979 is a novel compound with promising efficacy on smoker which have been assessed on phase I studies.
This is a multicenter,randomized, double blind, placebo controlled, phase IIb trial with parallel group to assess safety and efficacy of BP1.4979 in smoker.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo during 3 months
干预措施: Placebo (Drug)
BP1.4979 3mg
BP1.4979 3mg during 3 months
干预措施: BP1.4979 (Drug)
BP1.4979 10mg
BP1.4979 10mg during 3 months
干预措施: BP1.4979 (Drug)
BP1.4979 15mg
BP1.4979 15mg during 3 months
干预措施: BP1.4979 (Drug)
结局指标
主要结局
4-week prolonged abstinence from smoking cigarettes
时间窗: 4 weeks
The primary measure of efficacy will be 4-week prolonged abstinence from smoking cigarettes at the end of 12-week double-blind treatment phase (i.e. from V3 to V4). The continuous abstinence measured by subject diary and verified by exhaled CO (abstinent \< 10 ppm) will define response to the treatment.
次要结局
- Vital signs measures(26 weeks)
- 7-day tobacco Point Prevalence Abstinence (PPA)(7 days)
- Number of adverse events(26 weeks)