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Sandostatine® LP and Hyperinsulinism

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ClinicalTrials.gov Identifier: NCT00987168
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : December 19, 2013
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Congenital Hyperinsulinism Drug: Sandostatine LP Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2009
Primary Completion Date : April 2011
Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: Sandostatine LP Drug: Sandostatine LP
Intramuscular injection of Sandostatine LP, once per month Dosage : 10 mg, 20 mg, 30 mg

Primary Outcome Measures :
  1. Glycemia > or equal to 3 mmol/L, before and after 4 meals +Midnight + 4 am [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Abdominal ultra echography, before and after 6 month treatment [ Time Frame: 6 months ]
  2. Life quality [ Time Frame: 6 months ]

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Ages Eligible for Study:   6 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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): NCT00987168

Necker Hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Pascale De Lonlay, PUPH Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00987168     History of Changes
Other Study ID Numbers: CRC 07024
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: October 2010

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Congenital Hyperinsulinism
Sandostatine subcutaneous in 3 daily injections
Intramuscular injection of Sandostatine® LP per month

Additional relevant MeSH terms:
Congenital Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents