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Experimental Hydrolyzed infant formula

Phase 3

Infant | Unknown | Gastrointestinal |Abbott Laboratories|Last Updated: Feb 15, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

Experimental Hydrolyzed infant formula · 1 trial · 2 indications

Phase 3 1
NCT01573871Tolerance and Compliance of Infants Fed an Hydrolyzed Infant FormulaInfant
COMPLETED25 Analytics
PHASE3COMPLETED
Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula
InfantUnlock trial analytics

Study Endpoints

Primary Endpoints

Weight maintenance
14 days

Secondary Endpoints

Formula volume intake
14 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Hydrolyzed infant formulaEXPERIMENTALHydrolyzed infant formula to be fed ad libitum

Interventions

NameTypeDescription
Experimental Hydrolyzed infant formulaOTHERExperimental hydrolyzed infant formula to be fed ad libitum
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Eligibility Criteria

Age RangeN/A to 180 Days
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Infant is 0 to 180 days of age * Infant with persistent feeding intolerance symptoms; has had at least 1 formula switch OR infant is experiencing/being managed with an extensively hydrolyzed formula for suspected food protein intolerance or allergy or other condition where an ...

Countries:United States
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Frequently asked questions about Experimental Hydrolyzed infant formula

What is Experimental Hydrolyzed infant formula used for?

Experimental Hydrolyzed infant formula is an investigational product being studied for use in infants with gastrointestinal intolerance. It is a hydrolyzed formula designed for infant nutrition, and it is currently in Phase 3 clinical development by Abbott Laboratories.

Who makes Experimental Hydrolyzed infant formula?

Abbott Laboratories (NYSE: ABT) is developing Experimental Hydrolyzed infant formula. The product is an investigational hydrolyzed infant formula intended for infants with gastrointestinal intolerance, and it is currently in Phase 3 clinical development.

What phase is Experimental Hydrolyzed infant formula in?

Experimental Hydrolyzed infant formula is in Phase 3 clinical development. It is an investigational product, not yet approved, and has completed one Phase 3 trial. The study was a single-arm, uncontrolled trial conducted in the United States.

What clinical trials is Experimental Hydrolyzed infant formula in?

Experimental Hydrolyzed infant formula has one completed Phase 3 trial, NCT01573871, titled 'Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula.' The study enrolled 25 infants with gastrointestinal intolerance in the United States and was uncontrolled.

Is Experimental Hydrolyzed infant formula FDA approved?

Experimental Hydrolyzed infant formula is not FDA approved. It is an investigational product currently in Phase 3 clinical development. One Phase 3 trial has been completed, but the product remains under investigation and has not received regulatory approval.