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Sponsors and Collaborators: |
FDA Office of Orphan Products Development Children's Hospital of Philadelphia |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004700 |
OBJECTIVES:
Evaluate the safety and efficacy of long term recombinant human insulin-like growth factor I in children with hyperinsulinism.
Condition | Intervention | Phase |
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Hyperinsulinism |
Drug: insulin-like growth factor I |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Estimated Enrollment: | 16 |
Study Start Date: | May 1998 |
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.
Ages Eligible for Study: | 3 Months to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Study ID Numbers: | 199/13382, CHP-FDR001181-DBPC |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004700 History of Changes |
Health Authority: | United States: Federal Government |
endocrine disorders hyperinsulinism rare disease |
Hyperinsulinism Hypoglycemic Agents Metabolic Diseases Rare Diseases Mitogens |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hyperinsulinism Hypoglycemic Agents Metabolic Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Mitosis Modulators Mitogens Glucose Metabolism Disorders Pharmacologic Actions Insulin |