Status:
COMPLETED
Sandostatine® LP and Hyperinsulinism
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Novartis
Conditions:
Congenital Hyperinsulinism
Eligibility:
All Genders
6-16 years
Phase:
PHASE2
Brief Summary
To replace Sandostatine® in three daily subcutaneous injections by a single intramuscular injection of Sandostatine® LP per month in patients with a diffuse form of hyperinsulinism.
Detailed Description
Persistent hyperinsulinemic hypoglycemias of infancy (HI) are characterized by an inappropriate secretion of insulin responsible for profound hypoglycemias which require aggressive treatment to preven...
Eligibility Criteria
Inclusion
- congenital hyperinsulinism patients
- age of patients : 6 months to 16 years
- normoglycemia under sandostatine subcutaneous
- contraception efficiency
- signed informed consent
Exclusion
- refusal from parents
- vesicular lithiasis
- absence of social security
- hypersensitivity to octreotide or excipients
- pregnancy or nursing mother
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00987168
Start Date
May 1 2009
End Date
June 1 2011
Last Update
December 19 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Necker Hospital
Paris, France, 75015