NCT00487175已完成1 期
Tramadol and Pain Sensitization
University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2007年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Amplitude of the evoked potential elicited by a thermal stimulus on the arm with an induced hyperalgic area
研究概览
简要总结
Tramadol is a largely used analgesic drug. Its role however on sensitization as occurs for example in neuropathic pain is not very well known. This protocol aims therefore at studying the effect of tramadol in a human pain model with sensitization induced by a cold stimulus, using evoked potentials to elucidate how pain is modified when tramadol is administered.
详细描述
The study is a comparison of the analgesic of tramadol versus placebo in a pain model using evoked potentials. Evaluation criteria will be the amplitude of the evoked potential obtained defore and after treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men
- •Between 18 and 40 years old
- •Written consent given
排除标准
- •Concomitant medication
- •Tramadol hypersensibility
- •Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania
结局指标
主要结局
Amplitude of the evoked potential elicited by a thermal stimulus on the arm with an induced hyperalgic area
时间窗: with an induced hyperalgic area
次要结局
未报告次要终点
研究者
研究点 (2)
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