NCT00995033已完成2 期
A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 558
- 试验地点
- 2
- 主要终点
- Long term abstinence
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.
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
- •Smokes at least 10 cigarettes per day
- •Good general health
- •Negative pregnancy test prior to study entry
排除标准
- •Prior exposure to NicVAX or any other nicotine vaccine
- •Known allergic reaction to alum or any of the components of the vaccine
- •Use of systemic steroids, immunosuppressive agents or other medication that might interfere with an immune response
- •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
- •Previous intolerance to varenicline
- •Inability to fulfill all visits for approximately 54 weeks
研究组 & 干预措施
NicVAX conjugate vaccine
Experimental
干预措施: NicVAX vaccine (Biological)
NicVAX conjugate vaccine
Experimental
干预措施: Varenicline (Drug)
Placebo
Placebo Comparator
Biological
干预措施: Placebo (Biological)
Placebo
Placebo Comparator
Biological
干预措施: Varenicline (Drug)
结局指标
主要结局
Long term abstinence
时间窗: one year
次要结局
- Safety, immunogenicity(continuous assessment throughout the one year study duration)
- Abstinence(continuous assessment throughout the one year study duration)
- Lapse and relapse rate(continuous assessment throughout the one year study duration)
- Withdrawal symptoms(continuous assessment throughout the one year study duration)
研究者
研究点 (2)
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