NCT00202696已完成2 期
A Single Center Evaluation of Nalmefene HCl Versus Placebo on Smoking Cessation
Somaxon Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2005年9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
- 76
- 试验地点
- 1
- 主要终点
- Assess the efficacy of 2 doses of nalmefene relative to placebo
研究概览
简要总结
To determine if nalmefene is safe and effective in smoking cessation.
详细描述
Single centered, randomized, placebo-controlled,double-blind, outpatient pilot study to evaluate the efficacy, safety and tolerability of 2 doses of nalmefene on 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smokers in good general health self reporting more than 15 cigarettes per day
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
Nalmefene 40 mg
干预措施: nalmefene (Drug)
2
Experimental
Nalmefene 80 mg
干预措施: nalmefene (Drug)
3
Other
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Assess the efficacy of 2 doses of nalmefene relative to placebo
次要结局
- Evaluate the safety and tolerability of 2 doses of nalmefene
研究者
研究点 (1)
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