NCT00260325已完成4 期
Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia: a Randomized Controlled Trial in Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Reduction in the area of secondary hyperalgesia
研究概览
简要总结
Tis study was designed to test the hypothesis that pretreatment with valdecoxib, prior to injury could reduce or prevent the development of secondary hyperalgesia around the area of primary injury. A heat/capsaicin model of induced hyperalgesia was tested in healthy volunteers in a randomized, double blind, cross-over trial of a single dose of 40 mg vadecoxib versus control. Subjects rated pain intesnsity and unpleasantness following heat stimulation of the forearm, the area of hyperalgesia was also mapped over the course of the experiment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy male of non-pregnant female; 18yo or older
- •not currently taking NSAID
- •able and willing to provide informed consent
- •willing to avoid other NSAIDs in 24 hour period following study
- •no known hypersentitivites or contraindications to NSAIDS, sulfonomides or capsaicin
排除标准
- •pregnant or breast feeding
- •use of NSAIDS or other analgesic medications in past 7 days
- •unwilling or unable to give informed consent
- •contraindication to any study medication or other NSAID
结局指标
主要结局
Reduction in the area of secondary hyperalgesia
次要结局
- Reduction in pain unpleasantness
- Reduction in pain threshold
研究者
研究点 (2)
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