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Tolerability and Safety of An Infant Formula

This study has been completed.
Sponsor:
Information provided by:
Perrigo Nutritionals
ClinicalTrials.gov Identifier:
NCT00938483
First received: July 7, 2009
Last updated: July 14, 2009
Last verified: July 2009
  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:


Further study details as provided by Perrigo Nutritionals:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938483

Sponsors and Collaborators
Perrigo Nutritionals
Investigators
Study Director: Cynthia M Barber, PhD Perrigo Nutritionals
  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 Perrigo Nutritionals:
infant formula
cow's milk allergy

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

ClinicalTrials.gov processed this record on November 27, 2014