NCT04352686已完成不适用
Effects of Serotonin Agonist Buspirone on Multimodal Esophageal Stimulation in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Change in sensitivity to thermal stimulation
研究概览
简要总结
To investigate if buspirone, a partial 5-HT-1A receptor agonist, is able to modify esophageal sensitivity, assessed by the multimodal stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HV aged between 18 - 60 years
排除标准
- •history of psychiatric disease or a positive first degree psychiatric family history
- •pregnancy or lactation
- •concomitant administration of any centrally activating medication (anti-depressive medication, hypnotics, sedatives, anxiolytics, ...)
- •medication affecting esophageal motility
- •significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic)
- •prior history of esophageal, gastric surgery or endoscopic anti-reflux procedure
- •history of gastrointestinal disease
研究组 & 干预措施
Buspirone
Active Comparator
Buspirone 20 mg per oral
干预措施: Buspirone (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in sensitivity to thermal stimulation
时间窗: After 30 minutes after administration buspirone
To detect changes in thermal stimulation for sensitivity
次要结局
- Change in positive and negative affect score(At the beginning of the study and at the end of the multimodal stimulation)
- Change in sensitivity to mechanical stimulation(After 45 minutes after administration buspirone)
- Change in state trait and anxiety score(At the beginning of the study and at the end of the multimodal stimulation)
- Change in sensitivity to electrical stimulation(After 60 minutes after administration buspirone)
- Change in sensitivity to chemical stimulation(After 75 minutes after administration buspirone)
研究者
Prof Dr Jan Tack
Prof Dr
Universitaire Ziekenhuizen KU Leuven
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