Sandostatine® LP and Hyperinsulinism

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Novartis
• Treatments: Octreotide

Criteria

Inclusion Criteria:

• congenital hyperinsulinism patients

• age of patients : 6 months to 16 years

• normoglycemia under sandostatine subcutaneous

• contraception efficiency

• signed informed consent

Exclusion Criteria:

• refusal from parents

• vesicular lithiasis

• absence of social security

• hypersensitivity to octreotide or excipients

• pregnancy or nursing mother