NCT01908465已完成4 期
Peripheral Histamine 1 Receptor Blockade in IBS
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- Effect of treatment on global symptom relief (of IBS complaints)
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).
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 (IBS) (ROME III criteria): subtype with diarrhea or mixed form
- •age 18-65 years
排除标准
- •IBS subtype with constipation
- •medication: antidepressants or H1-receptor antagonists
- •pregnancy, breast feeding
- •co-morbidity: severe kidney- and/or liver disease or other gastrointestinal diseases
研究组 & 干预措施
Ebastine
Active Comparator
Ebastine
干预措施: Ebastine (Drug)
placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Effect of treatment on global symptom relief (of IBS complaints)
时间窗: after 12 weeks treatment
By mean of weekly GSRS (Gastrointestinal Symptom Rating Scale )questionnaires and weekly "SGA (Subject's Global Assessment) of relief" and "SGA of Abdominal Pain and Discomfort" questionnaires
次要结局
- Effect of treatment on stool consistency and frequency and other common IBS associated complaints (flatulence, urgency,...)(fter 12 weeks treatment)
研究者
研究点 (12)
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