NCT00738595已完成2 期
Phase II Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation, Effect on it Own and in Combination With Open Label Nicotine Replacement Therapy.
Evotec Neurosciences GmbH9 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 9
- 主要终点
- The four-week continuous quit rate over the last four weeks of treatment
研究概览
简要总结
This study will investigate the efficacy of EVT 302, a potent and selective inhibitor of Monoamine Oxidase - B, in improving quit rates in chronic cigarette smokers who are motivated to quit smoking. EVT 302 will be compared to placebo both with and without open label nicotine replacement therapy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smoker of at least 10 cigarettes daily
- •Motivated to quit smoking
- •Reports at least one unsuccessful attempt to quit in the last 2 years
- •In generally good health
- •Provides written informed consent to participate in the sudy
排除标准
- •Pregnant or nursing females.
- •Women of child-bearing potential must agree to use acceptable contraceptive precautions (contraceptive pill and one barrier method)during the study and for 2-months thereafter
- •History of anaphylaxis
- •History of alcohol or drug abuse
- •History of or current significant medical or psychiatric disorder
- •History or presence of cataract or abnormality identified by slit lamp investigation
- •Use of other MAO inhibitors, pethidine, SSRIs, tricyclic antidepressants,nasal or oral decongestants or cold medicines containing ephedrine, pseudoephedrine or other sympathomimetics.
- •Any medicine contraindicated for use with MAO inhibitors.
- •Have or be a carrier of hepatitis B or c or HIV 1 or 2
- •Use of tobacco products other than cigarettes
- •Use of nicotine replacement therapy in the past month
- •Received an investigational drug in the past 30 days
- •Previous participation in a study with a MAO-B inhibitor
研究组 & 干预措施
1
Experimental
EVT 302, 5 mg once Daily
干预措施: EVT 302 (Drug)
2
Placebo Comparator
Placebo once daily
干预措施: Placebo (Drug)
3
Experimental
EVT 302 plus open label Nicotine replacement
干预措施: EVT 302 plus open label Nicotine replacement (Drug)
4
Active Comparator
Placebo plus nicotine replacement therapy
干预措施: Placebo plus open label Nicotine Replacement (Drug)
结局指标
主要结局
The four-week continuous quit rate over the last four weeks of treatment
时间窗: Last 4 weeks of therapy
次要结局
- 7 -week abstinence(7 weeks post quit day)
- 7-day point prevalence quit rate(weekly for 7 weeks)
- Daily cigarettes smoked(Daily)
- Change from baseline in the number of cigarettes smoked(Week 8)
- Minnesota Nicotine Withdrawal Scale(Weekly)
- Brief Questionnaire of Smoking Urges(Weekly)
- Modified Cigarette Evaluation Questionnaire(Weekly)
- Adverse Events(Weekly)
- Laboratory investigations (Haematology & biochemistry)(Weekly)
- ECGs(Weekly)
研究者
研究点 (9)
Loading locations...
相似试验
终止
2 期
A Study to Evaluate the Pharmacodynamic Activity of E2082 in Adult Participants With Photosensitive EpilepsyPhotosensitive EpilepsyNCT03686033Eisai Inc.8
终止
2 期
A Study to Evaluate the Pharmacodynamic Activity of E2730 in Adult Participants With Photosensitive EpilepsyPhotosensitive EpilepsyNCT03603639Eisai Inc.6
已完成
2 期
Study Evaluating the Safety and Response of Fosbretabulin in Asian Patients With Polypoidal Choroidal Vasculopathy (PCV)Polypoidal Choroidal VasculopathyNCT01023295Mateon Therapeutics20
已完成
2 期
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic SteatohepatitisNon-Alcoholic SteatohepatitisNCT03421431Enanta Pharmaceuticals, Inc134
已完成
2 期
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary CholangitisPrimary Biliary CholangitisNCT03394924Enanta Pharmaceuticals, Inc68