A Study to Investigate the Effects of GSK598809 in Newly Abstinent Nicotine-dependent Subjects.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Continuous smoking abstinence
研究概览
简要总结
The purpose of this study is to determine the effect of GSK598809 as compared to placebo in preventing recently-quit smokers from going back to smoking.
详细描述
The primary objective of this study is to evaluate the efficacy of GSK598809 compared to placebo for the prevention of relapse to smoking in recently abstinent smokers. Subjects who meet eligibility criteria will enter a 4-week open label treatment period during which they will receive nicotine replacement therapy (NRT). Subjects who have achieved at least one week of abstinence during the last week of an open label treatment period will be randomized to either GSK598809 or placebo in the double-blind treatment period and followed for another 12 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •has smoked at least 10 cigarettes a day for at least 2 years
- •has had multiple previous attempts to quit smoking and relapsed to smoking.
- •generally healthy
排除标准
- •cannot be using smokeless tobacco of any type or has tried to quit with medicine.
- •does not abuse alcohol or drugs
- •certain emotional problems being treated with medications
- •pregnant or breast feeding female
研究组 & 干预措施
Placebo Arm
Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16.
干预措施: Placebo (Drug)
GSK598809 Arm
Subjects in GSK598809 arm will be taking GSK598809 once daily for 12 weeks from weeks 5 to 16.
干预措施: GSK598809 (Drug)
GSK598809 Arm
Subjects in GSK598809 arm will be taking GSK598809 once daily for 12 weeks from weeks 5 to 16.
干预措施: Nicotine Replacement Transdermal Patch (Drug)
Placebo Arm
Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16.
干预措施: Nicotine Replacement Transdermal Patch (Drug)
Placebo Arm
Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16.
干预措施: GSK598809 (Drug)
结局指标
主要结局
Continuous smoking abstinence
时间窗: weeks 13 through 16
次要结局
- drug exposure level(weeks 6-16)
- Weekly point prevalence abstinence(Weeks 6, 8, 10, 12, 14, and 16)
- safety endpoints including vital signs, weight, ECGs, safety laboratory test and adverse events(weeks 1 through 16 and follow-up phase)