NCT00836199已完成3 期
A 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
- 22
- 主要终点
- Evaluate NicVAX as an aid to smoking cessation for long term abstinence.
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 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.
时间窗: one year
次要结局
- Evaluate abstinence rates at multiple intervals(multiple time points)
- Evaluate safety and immunogenicity(mulitple time points)
- Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence.(multiple time points)
研究者
研究点 (22)
Loading locations...
相似试验
已完成
3 期
A Second Study of NicVAX/Placebo as an Aid for Smoking CessationSmoking CessationNCT01102114Nabi Biopharmaceuticals1,000
已完成
1 期
Antibody and Safety Study of 6 Doses of NicVAX in SmokersSmokingNCT00598325Nabi Biopharmaceuticals74
已完成
4 期
Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric DisordersSmoking CessationNCT01456936Pfizer8,144
尚未招募
不适用
Evaluation of a Smoking Cessation Intervention for Parents.Cigarette smoking, Intergenerational transmission of smoking-related cognitions and behaviourNL-OMON29474Radboud University Nijmegen, dep. of developmental psychopathology512
已完成
4 期
Clinical Trial to Evaluate the Efficacy of Smoking CessationSmoking CessationNCT01538394Josep Maria Ramon Torrell, PhD322