NCT00882375已完成不适用
Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy. A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, 52 Week Study in Smokers Motivated to Quit.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- McNeil AB
- 入组人数
- 479
- 试验地点
- 3
- 主要终点
- Self-reported continuous abstinence from smoking verified by exhaled CO levels of less than 10 ppm.
研究概览
简要总结
A comparison of a novel nicotine replacement therapy and placebo treatment in smokers motivated to quit smoking.
详细描述
Efficacy and safety study following use of a novel nicotine replacement therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older male and female cigarette smokers motivated and willing to stop smoking
- •Female participants of child-bearing potential should use a medically acceptable means of birth control.
- •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate.
排除标准
- •Unstable angina pectoris or myocardial infarction during the previous 3 months.
- •Pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential).
- •Participation in other clinical trials within the previous three months and during study participation.
研究组 & 干预措施
Nicotine
Experimental
Nicotine
干预措施: Nicotine (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Self-reported continuous abstinence from smoking verified by exhaled CO levels of less than 10 ppm.
时间窗: at weeks 2, 6, 24 and 52
次要结局
- Self-reported continuous abstinence from smoking, verified by exhaled CO levels of less than 10 ppm.(weeks 2, 4, 8, 12, 16, and 20)
- Self-reported 7-day point prevalence abstinence from smoking verified by exhaled CO levels of less than 10 ppm.(weeks 4, 6, 8, 12, 16, 20, 24, and 52)
- Ratings of craving/urge to smoke and withdrawal symptoms.(baseline to 24 weeks)
- Cotinine levels in saliva.(baseline, and weeks 2, 6, 12 and 24)
- Product acceptability(weeks 1, 6 and 12)
研究者
研究点 (3)
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