NCT00736047已完成2 期
A Double Blind, Placebo-controlled, Multi-centre Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of Repeated s.c Administrations of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Smoking status
研究概览
简要总结
This study is designed to determine the efficacy of high nicotine-specific antibody titers in smoking cessation.
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
- •Healthy male and female smoking subjects age 18 to 65 years of age
- •Subjects must be smoking 10 or more cigarettes per day during the past 12 months
- •The exhaled breath carbon monoxide (CO) concentration must be 10 ppm or more at screening. Urine cotinine at screening must be positive.
- •The Fagerström Test for Nicotine Dependence (FTND) score of 5 or above at screening.
排除标准
- •Attempted to quit smoking in the three (3) months.
- •Prior use of smoking cessation aid.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
2
Placebo Comparator
干预措施: Placebo (Biological)
1
Active Comparator
干预措施: NIC002 (Biological)
结局指标
主要结局
Smoking status
时间窗: 12 weeks
Exhaled carbon monoxide
时间窗: 12 weeks
次要结局
- Smoking status at various time intervals from target quit date to the end of the study(52 weeks)
- Immunogenicity (specific anti-nicotine antibodies in serum)(52 weeks)
- Safety and tolerability(52 weeks)
研究者
研究点 (2)
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