NCT00938483
Completed
Not Applicable
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
ConditionsMilk Hypersensitivity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Milk Hypersensitivity
- Sponsor
- Perrigo Nutritionals
- Enrollment
- 108
- Primary Endpoint
- Infant reactivity to an extensively hydrolyzed infant formula
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
The purpose of this study is to evaluate an extensively hydrolyzed formula in infants with cow's milk allergy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Infant reactivity to an extensively hydrolyzed infant formula
Time Frame: 29 days
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