NCT01144832已完成4 期
IBS Treatment With H1-receptor Antagonists
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Effect of treatment on visceral sensitivity measured with rectal barostat.
研究概览
简要总结
Purpose:
To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the H1-receptor antagonist ebastine.
Design:
Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment with ebastine 20mg once daily or placebo (1:1 randomization).
End points:
End point is the effect of treatment on clinical symptoms and visceral hypersensitivity which will be evaluated with a barostat test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Irritable Bowel Syndrome (ROME III criteria)
- •age 18-65 years
排除标准
- •medication: antidepressants or H1-receptor antagonists
- •pregnancy, breast feeding
- •co-morbidity: severe kidney- and/or liver disease
研究组 & 干预措施
placebo capsule
Placebo Comparator
干预措施: placebo capsule (Drug)
ebastine
Active Comparator
干预措施: ebastine (Drug)
结局指标
主要结局
Effect of treatment on visceral sensitivity measured with rectal barostat.
时间窗: after 12 weeks treatment
次要结局
- Effect of treatment on IBS symptoms.(after 12 weeks treatment)
研究者
研究点 (1)
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