Status:
COMPLETED
Efficacy Study of Recombinant Growth Hormone on Muscle Function in Children Long-term Treated With Glucocorticoid
Lead Sponsor:
Association REMEDE
Collaborating Sponsors:
Pfizer
Conditions:
Chronic Disease
Glucocorticoid Therapy, Response to
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief Summary
Children suffering from chronic disease and receiving long-term glucocorticoid therapy suffer over years from severe growth retardation and profoundly altered body composition. They consist in a marke...
Detailed Description
The aim of the present protocol is to evaluate the effects of GH treatment in long-term steroid treated children, on muscle mass, and muscle strength. It will be an open, randomized, controlled, 2-par...
Eligibility Criteria
Inclusion
- Measured Height below -2 SD
- Bone age below 13 years for a boy and below 11 years for a girl
- Glucocorticosteroid treatment for 12 months at least
- Glucocorticosteroid dose above or equal to 0.2 mg/kg/day of prednisone or equivalent dose over the last 12 months
- Glucocorticosteroid treatment is anticipated to be sustained for 1 more year at least
- The child benefits of the French social security cover
- Child who has never been treated by GH.
- Evidence of a personally signed and dated informed consent document indicating that the patient's parents/guardians and from the patient himself/herself if he/she is able to receive and understand the information have been informed of all pertinent aspects of the study.
- No glucose intolerance or diabetes mellitus on an Oral Glucose Tolerance Test dated less than 3 months
Exclusion
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00813189
Start Date
April 1 2005
End Date
May 1 2012
Last Update
May 5 2015
Active Locations (1)
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1
Hôpital Robert Debré
Paris, France, 75019