NCT00276328已完成4 期
Efficacy of Diosmectite (Smecta®) in the Treatment of Acute Diarrhoea in Adults. A Multicentre, Randomised, Double Blind, Placebo Controlled, Parallel Groups Study.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 346
- 试验地点
- 62
- 主要终点
- Time to recovery ie time (hours) from the first sachet intake to the first formed stool (this formed stool must have been followed by a non-watery stool)
研究概览
简要总结
The purpose of this study is to evaluate whether Smecta® is more effective than placebo with respect to time to recovery following an acute diarrhoea episode.
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
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
- •Acute diarrhoea episode defined as at least 3 watery stools per day for 48 hours or less
- •Patient with, usually, normal bowel habits, i.e. at least 3 stools per week and no more than 3 stools per day
排除标准
- •Gross blood, pus in the stools
- •Fever >39ºC
- •Other episode of acute watery diarrhoea within the last 30 days
- •History of chronic diarrhoea or motor diarrhoea
结局指标
主要结局
Time to recovery ie time (hours) from the first sachet intake to the first formed stool (this formed stool must have been followed by a non-watery stool)
次要结局
- Number of stools and number of watery stools per 12 hour period
- Global evaluation of efficacy by the patient at Day 4 and Day 8 visits by a mean Visual Analogue Scale (VAS)
- Time (hours) from first sachet intake to the last watery stool
- % of patients with recovery, per 12 hour period
- % of patients with associated symptoms such as nausea, abdominal pain, anal irritation, per 12 hour period
研究者
研究点 (62)
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