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Trial record 2 of 1298 for:    Hyperinsulinism
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Sandostatine® LP and Hyperinsulinism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Novartis
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00987168
First received: September 29, 2009
Last updated: October 11, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Intervention Phase
Congenital Hyperinsulinism
 Drug: Sandostatine LP
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Hypoglycemia
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Glycemia > or equal to 3 mmol/L, before and after 4 meals +Midnight + 4 am [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Abdominal ultra echography, before and after 6 month treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Life quality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: May 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sandostatine LP Drug: Sandostatine LP
Intramuscular injection of Sandostatine LP, once per month Dosage : 10 mg, 20 mg, 30 mg
Other Name: Sandostatine LP

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987168

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

No publications provided

Responsible Party: Aurelie.Guimfack, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00987168     History of Changes
Other Study ID Numbers: CRC 07024
Study First Received: September 29, 2009
Last Updated: October 11, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Hyperinsulinism
Persistent Hyperinsulinemia Hypoglycemia of Infancy
Glucose Metabolism Disorders
Metabolic Diseases
Infant, Newborn, Diseases
Hypoglycemia
 Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 16, 2013