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Peptide based enteral formula

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

Peptide based enteral formula · 1 trial · 2 indications

Phase 3 1
NCT01191112Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric PopulationGastrointestinal Diseases
COMPLETED27 Analytics
PHASE3COMPLETED
Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population
Gastrointestinal DiseasesUnlock trial analytics

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 to 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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Frequently asked questions about Peptide based enteral formula

What is Peptide based enteral formula used for?

Peptide based enteral formula is used for gastrointestinal diseases and feeding intolerance. It is being studied in a pediatric population to evaluate its safe use and tolerance. The drug is currently in Phase 3 clinical development for these gastrointestinal conditions.

Who makes Peptide based enteral formula?

Abbott Laboratories (ticker: ABT) is developing Peptide based enteral formula. The company is conducting clinical trials to evaluate the safety and tolerance of this product in pediatric patients with gastrointestinal diseases and feeding intolerance.

What phase is Peptide based enteral formula in?

Peptide based enteral formula is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 3 trial has been completed to assess its safety and tolerance in a pediatric population.

What clinical trials is Peptide based enteral formula in?

Peptide based enteral formula has one completed clinical trial, NCT0119112, titled 'Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population'. This Phase 3 study enrolled 27 participants in Canada and was not randomized or blinded.

Is Peptide based enteral formula FDA approved?

Peptide based enteral formula is not FDA approved. It is an investigational product currently in Phase 3 clinical development. The completed trial, NCT0119112, evaluated safety and tolerance in a pediatric population with gastrointestinal diseases and feeding intolerance.