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Experimental Hydrolyzed infant formula

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01573871Tolerance and Compliance of Infants Fed an Hydrolyzed Infant FormulaPHASE3 COMPLETED 25Feb 1, 2012Sep 1, 2012Feb 15, 20133 United States
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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 — 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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