NCT00366236已完成3 期
Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Tablets in the Treatment of Diarrhea Caused by Entamoeba Histolytica in Adults and Adolescents
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Resolution of clinical symptoms of amebiasis
研究概览
简要总结
The purpose of this study is to determine the effect of nitazoxanide tablets in treating diarrhea caused by Entamoeba histolytica in adults and adolescents.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥12 years.
- •Patients with diarrhea (≥3 bowel movements/day) with one or more enteric symptoms such as bloody stools, rectal bleeding or enlarged colon.
- •Positive stool ELISA test for Entamoeba histolytica within 7 days prior to enrollment.
排除标准
- •Patients with identified causes of diarrhea other than E. histolytica.
- •Use within 2 weeks of enrollment of any drug or therapy with possible anti-protozoal activity.
- •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.
- •Patients with amebic liver abscess.
- •Patients known to have or suspected of having AIDS.
- •Patient with immune deficiencies.
结局指标
主要结局
Resolution of clinical symptoms of amebiasis
次要结局
- Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples
- Time from initiation of treatment to passage of last unformed stool
研究者
研究点 (3)
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