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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00004700
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
Sponsor:
Information provided by:

Study Description
Brief Summary:

OBJECTIVES:

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


Condition or disease Intervention/treatment Phase
Hyperinsulinism Drug: insulin-like growth factor I Phase 2

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.

Completion date provided represents the completion date of the grant per OOPD records


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 1995
Estimated Study Completion Date : January 1999

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004700


Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Study Chair: Pinchas Cohen Children's Hospital of Philadelphia
More Information

ClinicalTrials.gov Identifier: NCT00004700     History of Changes
Other Study ID Numbers: 199/13382
CHP-FDR001181-DBPC
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 1999

Keywords provided by FDA Office of Orphan Products Development:
endocrine disorders
hyperinsulinism
rare disease

Additional relevant MeSH terms:
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Mitogens
Complement Factor I
Mecasermin
Hypoglycemic Agents
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Growth Substances