NCT00917696已完成1 期
A Randomized, Double Blind, Placebo Controlled, Crossover Clinical Trial to Evaluate the Effects of ATP-Induced Pain (AIP) and ATP-induced Dermal Vasodilation (AIDV) by Iontophoresis in Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Degree of pain induced by ATP vs. saline iontophoresis
研究概览
简要总结
This study will evaluate ATP-induced Pain (AIP) and ATP-induced dermal vasodilation (AIDV) as target engagement tools for future development of analgesics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is in generally good health
- •Subject is willing to abstain from smoking within 24 hours of each iontophoresis treatment and limit smoking to 5 or less cigarettes per week during the study
排除标准
- •Subject has a history of dermatitis, psoriasis, or eczema
- •Subject has active asthma and/or hay fever at the time of the screening visit
- •Subject is unable to refrain from use of analgesics within 3 days prior to each treatment period
研究组 & 干预措施
1
Active Comparator
ATP
干预措施: Comparator: Iontophoresis and Laser Doppler with ATP (Procedure)
2
Placebo Comparator
Saline
干预措施: Comparator: Iontophoresis and Laser Doppler with Saline (Procedure)
结局指标
主要结局
Degree of pain induced by ATP vs. saline iontophoresis
时间窗: 4 minutes
Increase in blood flow induced by ATP iontophoresis
时间窗: 8 minutes
次要结局
- Test-retest reproducibility and intra-subject variability of AIP and AIDV(8 minutes)
研究者
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