NCT00635401已完成2 期
A Multicenter, Open-Label Study Exploring the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Carbon monoxide (CO)-confirmed 4-week continuous quit rate (4-week CQR) from Weeks 4 to 7.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of varenicline in Japanese smokers. Efficacy is evaluated by continuous quit rate and withdrawal symptoms of smokers. Safety is evaluated by adverse events, laboratory tests, and other safety tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese smokers motivated to quit smoking
- •No period without smoking of more than 3 months
- •Smoked an average of at least 10 cigarettes/day in the past year
排除标准
- •Subjects who have used nicotine replacement therapy within 1 month of the study screening visit
- •Subjects intending to use nicotine replacement therapy or other smoking cessation treatments during the study
研究组 & 干预措施
0.5 mg BID
Experimental
干预措施: Varenicline (Drug)
结局指标
主要结局
Carbon monoxide (CO)-confirmed 4-week continuous quit rate (4-week CQR) from Weeks 4 to 7.
时间窗: Weeks 4-7
次要结局
- CO-confirmed 7-day Point Prevalence from Week 2 through Week 7.(Weeks 2-7)
- Continuous abstinence rate from target quit date (TQD) from Week 2 through Week 7.(Weeks 2-7)
- Average number of daily cigarettes smoked from Week 2 through Week 7.(Weeks 2-7)
- Assessment of withdrawal symptoms by Minnesota Nicotine Withdrawal Scales (MNWS) from Week 2 through Week 7.(Weeks 2-7)
- Assessment of satisfaction (desirable and aversive effects) obtained from smoking by Smoking Effects Inventory (SEI) (administered only to subjects who had smoked since the previous assessment) from Week 2 through Week 7.(Weeks 2-7)
- Assessment of tobacco craving by the Brief Questionnaire of Smoking Urges (QSU-Brief) from Week 2 through Week 7.(Weeks 2-7)
- Assessment of the effect of smoking cessation on subjects' quality of life by the Smoking Cessation Quality of Life (SCQoL) questionnaire from Week 2 through Week 7.(Weeks 2-7)
- Adverse events, laboratory test changes throughout the study.(Weeks 1-7)
研究者
研究点 (1)
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