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Formula for Children With Cow's Milk Allergy

Primary Purpose

Milk Allergy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental Extensively Hydrolyzed Formula
Active Comparator Formula
Sponsored by
Perrigo Nutritionals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Milk Allergy

Eligibility Criteria

undefined - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Good health
  • Parent/guardian must be willing to provide informed consent
  • Parent/guardian agrees to feed study formula provided
  • Confirmation of Cow's Milk Allergy

Exclusion Criteria:

  • No clinically significant abnormal findings on medical history, laboratory results, and physical exam.
  • No medications that may interfere with or impact evaluation of the study assessments
  • Allergy to extensively hydrolyzed casein formula
  • Tolerance of 200 ml of cow's milk, cow's milk-based formula or food products containing intact cow's milk protein within 2 weeks of the Screening Visit
  • Participation in another clinical trial within 30 days of screening where they are are receiving an active intervention

Sites / Locations

  • Clinical Research Center of Alabama
  • Arkansas Children's Hosptial
  • Pediatric Care Medical Group
  • Children's Hospital of Los Angeles
  • Choc Psf, Amc
  • Allergy Medical Group of the North Area, INC
  • Allergy & Asthma Medical Group and Research Center, APC
  • 1st Allergy and Clinical Research Group, INC, d/b/a IMMUNOe International Research Centers
  • Sneeze Wheeze and Itch Associates
  • Institute for Allergy and Asthma
  • Einstein Consulting Services, LLC & Virgo Carter Pediatrics
  • Clinical Research Institute
  • Clinical Research Solutions, LLC
  • Allergy, Asthma, and Clinical Research Center
  • Carolina Ear Nose and Throat Clinic
  • TTS Research
  • STAAMP Clinical Research
  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

New Extensively Hydrolyzed Formula

Comparator Formula

Arm Description

Administered in context of oral food challenge and then for 16 weeks.

Administered in context of oral food challenge and then for 16 weeks.

Outcomes

Primary Outcome Measures

Incidence of Allergic Reaction

Secondary Outcome Measures

Growth
Anthropometric measurements of weight in all enrolled subjects.
Growth
Anthropometric measurements of length/height in all enrolled subjects.

Full Information

First Posted
December 2, 2014
Last Updated
June 7, 2017
Sponsor
Perrigo Nutritionals
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1. Study Identification

Unique Protocol Identification Number
NCT02317952
Brief Title
Formula for Children With Cow's Milk Allergy
Official Title
A Double-Blind, Randomized, Crossover Allergy Study of an Experimental Formula Followed by a 16 Week Double Blind Feeding Period to Assess Growth, Safety and Development of Tolerance to Cow's Milk Protein
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Perrigo Nutritionals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if a new extensively hydrolyzed formula can be consumed by children with Cow's Milk Allergy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Milk Allergy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
New Extensively Hydrolyzed Formula
Arm Type
Experimental
Arm Description
Administered in context of oral food challenge and then for 16 weeks.
Arm Title
Comparator Formula
Arm Type
Active Comparator
Arm Description
Administered in context of oral food challenge and then for 16 weeks.
Intervention Type
Other
Intervention Name(s)
Experimental Extensively Hydrolyzed Formula
Intervention Type
Other
Intervention Name(s)
Active Comparator Formula
Primary Outcome Measure Information:
Title
Incidence of Allergic Reaction
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Growth
Description
Anthropometric measurements of weight in all enrolled subjects.
Time Frame
16 weeks
Title
Growth
Description
Anthropometric measurements of length/height in all enrolled subjects.
Time Frame
16 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Good health Parent/guardian must be willing to provide informed consent Parent/guardian agrees to feed study formula provided Confirmation of Cow's Milk Allergy Exclusion Criteria: No clinically significant abnormal findings on medical history, laboratory results, and physical exam. No medications that may interfere with or impact evaluation of the study assessments Allergy to extensively hydrolyzed casein formula Tolerance of 200 ml of cow's milk, cow's milk-based formula or food products containing intact cow's milk protein within 2 weeks of the Screening Visit Participation in another clinical trial within 30 days of screening where they are are receiving an active intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy M Barber, PhD
Organizational Affiliation
Perrigo Nutritionals
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Arkansas Children's Hosptial
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Pediatric Care Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Choc Psf, Amc
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Allergy Medical Group of the North Area, INC
City
Roseville
State/Province
California
ZIP/Postal Code
95678
Country
United States
Facility Name
Allergy & Asthma Medical Group and Research Center, APC
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
1st Allergy and Clinical Research Group, INC, d/b/a IMMUNOe International Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Sneeze Wheeze and Itch Associates
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Institute for Allergy and Asthma
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Einstein Consulting Services, LLC & Virgo Carter Pediatrics
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Clinical Research Institute
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Clinical Research Solutions, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Allergy, Asthma, and Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Carolina Ear Nose and Throat Clinic
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
TTS Research
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Facility Name
STAAMP Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78251
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

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Formula for Children With Cow's Milk Allergy

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