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Tolerability and Safety of An Infant Formula

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ClinicalTrials.gov Identifier: NCT00938483
Recruitment Status : Completed
First Posted : July 14, 2009
Last Update Posted : July 15, 2009
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment
Milk Hypersensitivity Other: Nutramigen Lipil (Infant formula)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
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
Study Start Date : August 2007
Primary Completion Date : September 2008
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. Infant reactivity to an extensively hydrolyzed infant formula [ Time Frame: 29 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Weeks   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938483


Sponsors and Collaborators
Perrigo Nutritionals
Investigators
Study Director: Cynthia M Barber, PhD Perrigo Nutritionals
More Information

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
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: July 15, 2009
Last Verified: July 2009

Keywords provided by Perrigo Nutritionals:
infant formula
cow's milk allergy

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