Tolerability and Safety of An Infant Formula

July 14, 2009 updated by: Perrigo Nutritionals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extensively hydrolyzed infant formula
New extensively hydrolyzed formula, NPS-202
Other: Nutramigen Lipil (Infant formula)
Other Names:
  • 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 Names:
  • Extensively hydrolyed infant formula (Nutramigen Lipil)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infant reactivity to an extensively hydrolyzed infant formula
Time Frame: 29 days
29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perrigo Nutritionals

Investigators

  • Study Director: Cynthia M Barber, PhD, Perrigo Nutritionals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

July 7, 2009

First Submitted That Met QC Criteria

July 13, 2009

First Posted (Estimate)

July 14, 2009

Study Record Updates

Last Update Posted (Estimate)

July 15, 2009

Last Update Submitted That Met QC Criteria

July 14, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-0010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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