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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 1999 by FDA Office of Orphan Products Development. Recruitment status was Active, not recruiting

First Received on February 24, 2000. Last Updated on June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Insulin Insulin beef Insulin-like growth factor I Mecasermin rinfabate

U.S. FDA Resources

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

No publications provided

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

Keywords provided by FDA Office of Orphan Products Development:

endocrine disorders
hyperinsulinism
rare disease

Additional relevant MeSH terms:

Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Complement Factor I
Mitogens
Insulin
Complement Inactivating Agents

Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents

ClinicalTrials.gov processed this record on February 12, 2012