NCT01328925已完成2 期
Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time from first dose to resolution of symptoms.
研究概览
简要总结
The purpose of this study is to determine the effectiveness of nitazoxanide suspension compared to placebo in treating rotavirus disease in pediatric patients less than 6 years of age.
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
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age < 6 years.
- •Patients with diarrhea (defined as 3 or more liquid stools per day).
- •Stool positive for rotavirus by ELISA.
排除标准
- •Other identified causes of diarrhea at screening (pathogenic protozoa, bacteria, viruses or lactose intolerance).
- •Serious systemic disorders incompatible with the study.
研究组 & 干预措施
Nitazoxanide Oral Suspension
Experimental
Nitazoxanide Oral Suspension 100 mg/5 ml
干预措施: Nitazoxanide (Drug)
Placebo Oral Suspension
Placebo Comparator
Placebo Oral Suspension
干预措施: Nitazoxanide (Drug)
结局指标
主要结局
Time from first dose to resolution of symptoms.
时间窗: Up to 14 days
Resolution of all gastrointestinal symptoms associated with viral diarrhea at enrollment including abdominal pain or tenderness, distention, etc. with the patient not requiring anti-motility or other palliative treatment. Symptom resolution must be maintained for at least 48 hours to be considered valid.
次要结局
- Time from first dose to virologic response(Up to 14 days)
- Time from first dose to hospital discharge(Up to 14 days)
- Volume of oral rehydration solutions consumed(Up to 14 days)
- Frequency of intravenous rehydration required(Up to 14 days)
- Stool weight(Up to 14 days)
研究者
研究点 (1)
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