Champix Observational Investigation In The Cessation of Smoking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 567
- 试验地点
- 1
- 主要终点
- Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of varenicline in the real-world environment of smokers attending primary care in routine clinical practice with the addition of being offered behavioral support "Life REWARDS"TM. This is a non-interventional study.
详细描述
Sampling Method Details: Patients as they come to surgeries for smoking cessation treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •The patients enrolled should be of legal adult age who regularly smoke and of which the main tobacco product is cigarettes.
- •The patients must be willing to make an attempt to stop smoking.
排除标准
- •All patients enrolled should meet the usual prescribing criteria for varenicline as per SmPC and should be entered into the trial at the Investigators discretion.
研究组 & 干预措施
1. Non-interventional
Patients prescribed varenicline in a non interventional manner.
干预措施: Varenicline (Drug)
结局指标
主要结局
Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs)
时间窗: Baseline through Week 12 or Week 24
Non-serious AEs are any untoward medical occurrence in a clinical investigation (subject administered a product or medical device) observed or volunteered through 7 days after the last dose of study drug regardless of suspected causal relationship; SAEs are any untoward medical occurrence that results in death; is life-threatening; requires hospitalization or prolongation of hospitalization; results in disability or incapacity; congenital anomaly or birth defect observed or volunteered through 28 days after the last dose of study drug, regardless of suspected causal relationship.
次要结局
- Number of Treatment Responders in Belgium at Week 12 and at Week 24(Week 12 and Week 24)
- Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks(Week 12)
- Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks(Week 12 and Week 24)
- Number of Treatment Responders at Week 12(Week 12)
- Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11(Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11)
- Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11(Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11)
- Number of Participants for Whom a Maintenance Period of Varenicline Was Prescribed at the End of Week 12(Week 12)
- Number of Participants Who Received Varenicline, by Duration of Treatment in Days(Baseline through Week 12 or Week 24)
- Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program(Week 12)
- Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium(Week 7 and Week 13 or 14 (Week 13/14))