Tolerability and Safety of An Infant Formula

Milk Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938483
• Other study ID #: CTP-0010
• Status: Completed
• Phase: N/A
• First received: July 7, 2009
• Last updated: July 14, 2009
• Start date: August 2007
• Est. completion date: January 2009

Study information

• Verified date: July 2009
• Source: Perrigo Nutritionals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate an extensively hydrolyzed formula in infants with cow's milk allergy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver)

Related Conditions & MeSH terms

• Hypersensitivity
• Milk Hypersensitivity

Intervention

Other:
• Nutramigen Lipil (Infant formula)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Perrigo Nutritionals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant reactivity to an extensively hydrolyzed infant formula		29 days	Yes