NCT00352989已完成3 期
Efficacy of Diosmectite (SMECTA®) in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children. A Phase IIIB, Placebo Controlled, Randomized, Double Blind, Parallel Groups, Multicenter Study.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 302
- 试验地点
- 19
- 主要终点
- Cumulative faecal output (g/kg of body weight)
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of Smecta at decreasing stool weight, when compared to placebo, in the treatment of acute diarrhoea in children.
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
- 1 Month 至 36 Months（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •acute watery diarrhoea defined as at least 3 watery stools per 24 hours
- •duration of watery diarrhoea of less than 72 hours and with at least 1 watery stool for the last 12 hours
- •dehydration signs requiring oral rehydration according to current WHO guidelines
排除标准
- •severe dehydration that needs IV therapy
- •presence of gross blood in stools
- •fever >39 degrees Celsius
结局指标
主要结局
Cumulative faecal output (g/kg of body weight)
时间窗: 72 hours after first study drug intake
次要结局
- Tolerance of Smecta (assessed via adverse event reporting)(Till 7 days after the last study drug intake)
- Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance)(7 days after the first study drug intake)
- Faecal output (g/kg of body weight) per day(72 hours after the first study drug intake)
- Cumulative faecal output (g)(72 hours after the first study drug intake)
- Percentage of body weight gain in comparison with body weight at inclusion(Till 7 days after the first study drug intake)
- Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline)(7 days after the first study drug intake)
- Percentage of children with at least one formed stool (H12, H24, H36, H48, H60, H72, then daily until Day 7)(Till 7 days after first study drug intake)
- Daily until Day 7: stool frequency, watery stool number, formed stool number, soft stool number, percentage of patients with bottom skin irritation, percentage of patients with anal irritation, appetite on a 100mm visual analogue scale(Till 7 days after first study drug intake)
研究者
研究点 (19)
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