Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
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|ClinicalTrials.gov Identifier: NCT00004700|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Study Start Date :||August 1995|
|Estimated Study Completion Date :||January 1999|
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
|Study Chair:||Pinchas Cohen||Children's Hospital of Philadelphia|