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Tolerability and Safety of An Infant Formula

This study has been completed.
Sponsor:
Information provided by:
PBM Products
ClinicalTrials.gov Identifier:
NCT00938483
First received: July 7, 2009
Last updated: July 14, 2009
Last verified: July 2009
History of Changes
  Purpose

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


Condition Intervention
Milk Hypersensitivity
 Other: Nutramigen Lipil (Infant formula)

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by PBM Products:

Primary Outcome Measures:
  • Infant reactivity to an extensively hydrolyzed infant formula [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]

Enrollment: 108
Study Start Date: August 2007
Study Completion Date: January 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extensively hydrolyzed infant formula
New extensively hydrolyzed formula, NPS-202
 Other: Nutramigen Lipil (Infant formula)
Other Name: Extensively hydrolyed infant formula (Nutramigen Lipil)
Active Comparator: Infant formula - Extensively hydrolyzed Nutramigen Lipil
Currently marketed extensively hydrolyzed formula (Nutramigen Lipil)
 Other: Nutramigen Lipil (Infant formula)
Other Name: Extensively hydrolyed infant formula (Nutramigen Lipil)

  Eligibility

Ages Eligible for Study:   up to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938483

Sponsors and Collaborators
PBM Products
Investigators
Study Director: Cynthia M Barber, PhD PBM Products
  More Information

No publications provided

Responsible Party: Cynthia Barber, PhD, Vice President, Regulatory, Medical and Clinical Affairs, PBM Products, LLC
ClinicalTrials.gov Identifier: NCT00938483     History of Changes
Other Study ID Numbers: CTP-0010
Study First Received: July 7, 2009
Last Updated: July 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by PBM Products:
infant formula
cow's milk allergy

Additional relevant MeSH terms:
Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on June 17, 2013