NCT00987168

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 19, 2013

Status Verified

October 1, 2010

Enrollment Period

1.9 years

First QC Date

September 29, 2009

Last Update Submit

December 18, 2013

Conditions

Congenital Hyperinsulinism

Keywords

Congenital HyperinsulinismHypoglycemia,Sandostatine subcutaneous in 3 daily injectionsIntramuscular injection of Sandostatine® LP per month

Outcome Measures

Primary Outcomes (1)

  • Glycemia > or equal to 3 mmol/L, before and after 4 meals +Midnight + 4 am

    6 months

Secondary Outcomes (2)

  • Abdominal ultra echography, before and after 6 month treatment

    6 months

  • Life quality

    6 months

Study Arms (1)

Sandostatine LP

EXPERIMENTAL
Drug: Sandostatine LP

Interventions

Sandostatine LPDRUG

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

Sandostatine LP

Eligibility Criteria

Age6 Months - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • congenital hyperinsulinism patients
  • age of patients : 6 months to 16 years
  • normoglycemia under sandostatine subcutaneous
  • contraception efficiency
  • signed informed consent

You may not qualify if:

  • refusal from parents
  • vesicular lithiasis
  • absence of social security
  • hypersensitivity to octreotide or excipients
  • pregnancy or nursing mother

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker Hospital

Paris, 75015, France

Location

MeSH Terms

Conditions

Congenital HyperinsulinismHypoglycemia

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Pascale De Lonlay, PUPH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2009

First Posted

September 30, 2009

Study Start

May 1, 2009

Primary Completion

April 1, 2011

Study Completion

June 1, 2011

Last Updated

December 19, 2013

Record last verified: 2010-10

Locations

FR(1)