Phase II Long Term, Randomized Study of Recombinant Human Insulin-Like Growth Factor I in Children With Hyperinsulinism - Full Text View

Phase II Long Term, Randomized Study of Recombinant Human Insulin-Like Growth Factor I in Children With Hyperinsulinism

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	FDA Office of Orphan Products Development Children's Hospital of Philadelphia
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004700

Purpose

OBJECTIVES:

Evaluate the safety and efficacy of long term recombinant human insulin-like growth factor I in children with hyperinsulinism.

Condition	Intervention	Phase
Hyperinsulinism	Drug: insulin-like growth factor I	Phase II

Drug Information available for:

Insulin Insulin-like growth factor I Mecasermin rinfabate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	16
Study Start Date:	May 1998

Detailed Description:

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, cross-over study.

Patients are randomized to receive recombinant human insulin-like growth factor I (IGF-I) or placebo subcutaneously twice daily for 4 weeks. After a 2 week washout period, patients are crossed over to the other regimen for an additional 4 weeks.

Eligibility

Ages Eligible for Study:	3 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Diagnosis of hyperinsulinism (i.e., evidence of fasting hypoglycemia with inadequate suppression of insulin, normal pituitary and adrenal function, and increased insulin action) Suboptimal control of blood sugar (i.e., inability to fast at least 10 hours with a blood sugar of 60 mg/dL or greater) --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other major medical conditions No known adverse reaction to recombinant human insulin-like growth factor I

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004700

Sponsors and Collaborators

FDA Office of Orphan Products Development

Children's Hospital of Philadelphia

Investigators


Study Chair:	Pinchas Cohen	Children's Hospital of Philadelphia

More Information

Study ID Numbers:	199/13382, CHP-FDR001181-DBPC
First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004700
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

endocrine disorders

hyperinsulinism

rare disease

Study placed in the following topic categories:

Hyperinsulinism

Metabolic Diseases

Rare Diseases

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008