NCT00356967已完成3 期
An International 7-Week, Double-Blind, Placebo-Controlled, 2-Parallel Group Study to Assess the Efficacy of Dianicline 40 mg BID as an Aid to Smoking Cessation in Cigarette Smokers
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 602
- 试验地点
- 6
- 主要终点
- to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients
研究概览
简要总结
The primary objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are: to assess the craving for cigarettes, nicotine withdrawal symptoms and the safety of dianicline.
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
- •Outpatients over the legal age smoking at least 10 cigarettes per day for at least 2 months
排除标准
- •Insufficient level of motivation
- •Another participant in the household
- •Patients with current psychotic disorder or major depressive disorder
- •The investigator will evaluate whether there are other reasons why a patient may not participate.
结局指标
主要结局
to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients
exhaled carbon monoxide testing
and plasma cotinine measurements
次要结局
- questionnaire of smoking urge
- Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal
研究者
研究点 (6)
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