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Sandostatine® LP and Hyperinsulinism

NCT00987168 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-12-19

No results posted yet for this study

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.

Conditions

  • Congenital Hyperinsulinism

Interventions

DRUG

Sandostatine LP

Intramuscular injection of Sandostatine LP, once per month Dosage : 10 mg, 20 mg, 30 mg

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Pascale De Lonlay, PUPH · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-04-30
Completion
2011-06-30

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00987168 on ClinicalTrials.gov