NCT00302640已完成2 期
Multi-center, Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses 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
- 50
- 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 effect of nitazoxanide suspension in treating diarrhea caused by enteric viruses in children less than 12 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- — 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age <12 years.
- •Patients with diarrhea (defined as 3 or more stools per day with liquid or semi-solid consistency, the number and consistency of stools being unusual for that person).
- •Stool positive for adenovirus, norovirus or rotavirus by ELISA.
排除标准
- •Females who are pregnant, suspected of being pregnant or breastfeeding.
- •Other identified causes of diarrhea at screening.
- •Serious systemic disorders incompatible with the study.
研究组 & 干预措施
Nitazoxanide
Active Comparator
7.5mg/kg (age under 12 months), 5 mL (100mg nitazoxanide; age 1-3 years), 10 mL (200mg nitazoxanide; age 4-11 years) twice daily x 3 days
干预措施: Alinia (nitazoxanide) (Drug)
Placebo
Placebo Comparator
7.5mg/kg (age under 12 months), 5 mL (100mg nitazoxanide; age 1-3 years), 10 mL (200mg nitazoxanide; age 4-11 years) twice daily x 3 days
干预措施: Alinia (nitazoxanide) (Drug)
结局指标
主要结局
Time from first dose to resolution of symptoms.
时间窗: P-0.0105
Median time: 31 hours for nitazoxanide group and 75 hours for the placebo group
次要结局
- Virologic response (negative ELISA) at day 7-10.
研究者
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