Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Prolonged Diarrhea in Children
试验速览
- 阶段
- 3 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 was to determine the efficacy of nitazoxanide suspension compared to placebo in treating prolonged diarrhea 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diarrhea ≥3 days but <30 days duration.
- •No visible blood in stool.
排除标准
- •Use of any antibacterial, antiparasitic or antiviral drugs within 5 days of enrollment.
- •Females who are pregnant, suspected of being pregnant or breastfeeding.
- •Serious systemic disorders incompatible with the study.
- •History of hypersensitivity to nitazoxanide.
- •Patients in whom the possibility of receiving placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patient's illness according to the investigator's judgment.
- •Patients known to have or suspected of having AIDS or other immune deficiencies.
研究组 & 干预措施
Nitazoxanide Suspension
Nitazoxanide Oral Suspension 100 mg/5 ml for patients aged 1-3 years or Nitazoxanide Oral Suspension 200 mg/10 ml for patients aged 4-11 years
干预措施: Nitazoxanide (Drug)
Placebo Suspension
Placebo Oral Suspension 5 ml for patients aged 1-3 years and Placebo Oral Suspension 10 ml for patients aged 4-11 years
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 17 days
Resolution of symptoms defined as resolution of all gastrointestinal symptoms associated with prolonged 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 72 hours to be considered valid.
次要结局
未报告次要终点