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Peptide based enteral formula

Phase 3

Gastrointestinal Diseases | Unknown | Gastrointestinal |Abbott Laboratories|Last Updated: Mar 3, 2015

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
UNCONTROLLED
Total Trials1
Total Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01191112Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric PopulationPHASE3 COMPLETED 27Jan 1, 2011Nov 1, 2011Mar 3, 20151 Canada
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Study Endpoints
Primary Endpoints
Stool frequency
14 Days
Frequency and intensity of irritability, vomiting, distension
14 Days
Secondary Endpoints
Average Energy Intake
14 Days
Anthropometrics
14 Days
Medication Use
14 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Peptide Based enteral formulaEXPERIMENTAL -
Interventions
NameTypeDescription
Peptide based enteral formulaOTHERSole source nutrition as per HCP
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Eligibility Criteria
Age Range1 Year — 13 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or nonpregnant female between 1 and 13 years of age. * Subject is diagnosed with gastrointestinal dysfunction and/or feeding intolerance. * Subject requires enteral tube feeding as sole source of nutrition. Exclusion Criteria: * History of diabetes. * Requires artificia...

Countries:Canada
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