NCT00711048已完成1 期
A Phase I, Two Centre, Double-blind, Randomized, Cross-over Study to Evaluate AZD1386 in Single Doses of 30 mg and 95 mg Compared to Placebo in a Multimodal Experimental Pain Model on Esophageal Sensitivity and Development of Sensitization in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- VAS scale and clock
研究概览
简要总结
The purpose of the study is to compare sensitivity and sensitization of visceral pain in the esophagus using different pain stimuli
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of written consent
- •Clinically normal physical findings
- •Sensitization potential
排除标准
- •Clinically significant illness within 2 weeks prior to the first dose of investigational product
- •History of clinically significant disease
- •Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
研究组 & 干预措施
1
Experimental
30 mg, oral, single dose
干预措施: AZD1386 (Drug)
2
Experimental
95 mg, oral, single dose
干预措施: AZD1386 (Drug)
3
Placebo Comparator
Oral solution, single dose
干预措施: Placebo (Drug)
结局指标
主要结局
VAS scale and clock
时间窗: Several occasions during the study days
次要结局
- VAS scale and pressure, VAS scale and current, VAS scale and acid volume(Several occasions during the study days)
- Pharmacokinetic variables(Several occasions during the study days)
- Safety variables (adverse events, blood pressure, safety lab, ECG and body temperature)(Several occasions during the study days)
研究者
研究点 (1)
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