NCT00938483已完成不适用
A Multicenter, Single-blind, Randomized, Phase II Study of the Tolerability and Safety of NPS-202 in Infants With Clinically Diagnosed Cow's Milk Allergy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 主要终点
- Infant reactivity to an extensively hydrolyzed infant formula
研究概览
简要总结
The purpose of this study is to evaluate an extensively hydrolyzed formula in infants with cow's milk allergy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 1 Day 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically diagnosed CMA
- •</= 12 weeks at time of study entry
- •full-term infant
- •must be willing to use provided formula as sole source of nutrition
- •other than CMA, infant must be otherwise healthy
排除标准
- •underlying or confounding gastrointestinal abnormalities
- •infants born from an addictive situation, HIV positive
- •if parent/guardian is considered likely to be non-compliant with the protocol requirements
研究组 & 干预措施
Extensively hydrolyzed infant formula
Experimental
New extensively hydrolyzed formula, NPS-202
干预措施: Nutramigen Lipil (Infant formula) (Other)
Infant formula - Extensively hydrolyzed Nutramigen Lipil
Active Comparator
Currently marketed extensively hydrolyzed formula (Nutramigen Lipil)
干预措施: Nutramigen Lipil (Infant formula) (Other)
结局指标
主要结局
Infant reactivity to an extensively hydrolyzed infant formula
时间窗: 29 days
次要结局
未报告次要终点
研究者
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