NCT01271049终止不适用
A Double-blind, Randomized, Controlled Evaluation of the Tolerability of a Proprietary Oil Blend in Adults Residing in Areas Endemic for Helminth Infections.
Mondelēz International, Inc.1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Measure of Safety and Tolerability using the Reactogenicity Questionairre
研究概览
简要总结
The prevalence of intestinal helminths is worldwide. This study will evaluate the tolerability of a novel food product consumed by adults residing in an area endemic for helminths.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Male or Female adults, age 18-45 years old inclusive on date of screening
- •Showing presence of no or mild-moderate helminths
排除标准
- •Presence of heavy helminth load
- •Pregnant or lactating
- •Hepatosplenomegaly or clinically significant abnormal hemoglobin, LAT or creatinine
结局指标
主要结局
Measure of Safety and Tolerability using the Reactogenicity Questionairre
时间窗: 43 days
Reactogenicity will be assessed using a structured questionnaire on days 2, 14, 28, and 42 of the study. In addition, blood will be collected on study days 14 and 42 for assessment of basic hematologic and clinical chemistry parameters.
次要结局
未报告次要终点
研究者
研究点 (1)
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