NCT01102114已完成3 期
A Second Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy, Immunogenicity and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) as an Aid to Smoking Cessation
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 25
- 主要终点
- Evaluate NicVAX as an aid to smoking cessation for long term abstinence (by subject self-report and carbon monoxide confirmation).
研究概览
简要总结
The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.
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
- •Current smoker who smokes at least 10 cigarettes a day during the past year and wants to quit smoking.
- •Smokers who are in good general health.
排除标准
- •Prior exposure to NicVAX or any other nicotine vaccine.
- •Use of systemic steroids.
- •Cancer or cancer treatment in the last 5 years.
- •HIV infection.
- •History of drug or alcohol abuse or dependence within 12 months.
- •Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease.
- •Inability to fulfill all visits for approximately 52 weeks.
结局指标
主要结局
Evaluate NicVAX as an aid to smoking cessation for long term abstinence (by subject self-report and carbon monoxide confirmation).
时间窗: One year
次要结局
- Evaluate abstinence rates at multiple intervals (by subject self-report and carbon monoxide confirmation).(One year)
- Evaluate safety based on adverse events.(One year)
- Evaluate immunology based on serum antibody concentration.(One year)
- Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence (based on subject self-report).(One year)
研究者
研究点 (25)
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