NCT00542295已完成4 期
Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome. a 4-Week, Multicentre, Double-Blind, Randomised, Placebo-Controlled Phase IV Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 400
- 主要终点
- Subject self assessment of abdominal pain/discomfort
研究概览
简要总结
To assess the effectiveness of alverine citrate and simeticone on IBS symptoms according to the latest recommended design
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female ambulatory patients, aged 18-75 years
- •with IBS as defined by Rome III criteria
排除标准
- •Functional bowel disorder other than IBS,
- •Underlying cause for symptomatology, which excludes IBS diagnosis,
- •Gastro-intestinal cancer or significant gastro-intestinal surgical background,
- •Any acute/uncontrolled systemic pathology
研究组 & 干预措施
A
Experimental
干预措施: alverine citrate and simeticone (Drug)
B
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Subject self assessment of abdominal pain/discomfort
时间窗: Baseline and 4 weeks
次要结局
- IBS life impact, overall treatment assessment, concomitant factors(Baseline and 4 weeks)
研究者
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