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

July 7, 2009
July 14, 2009
August 2007
September 2008   (final data collection date for primary outcome measure)
Infant reactivity to an extensively hydrolyzed infant formula [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00938483 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Tolerability and Safety of An Infant Formula
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

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Milk Hypersensitivity
Other: Nutramigen Lipil (Infant formula)
Other Name: Extensively hydrolyed infant formula (Nutramigen Lipil)
  • Experimental: Extensively hydrolyzed infant formula
    New extensively hydrolyzed formula, NPS-202
    Intervention: Other: Nutramigen Lipil (Infant formula)
  • Active Comparator: Infant formula - Extensively hydrolyzed Nutramigen Lipil
    Currently marketed extensively hydrolyzed formula (Nutramigen Lipil)
    Intervention: Other: Nutramigen Lipil (Infant formula)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
January 2009
September 2008   (final data collection date for primary outcome measure)

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
Both
up to 12 Weeks
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00938483
CTP-0010
No
Cynthia Barber, PhD, Vice President, Regulatory, Medical and Clinical Affairs, PBM Products, LLC
PBM Products
Not Provided
Study Director: Cynthia M Barber, PhD PBM Products
PBM Products
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP