Brief Title
Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm
Official Title
Evolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By Genotonorm
Brief Summary
To estimate the evolution of height and growth rate over 5 years of growth hormone (GH)
treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the
good clinical and biological safety of GH treatment in such children
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population
Secondary Outcome
Mean Height
Condition
Growth Hormone Deficiency
Intervention
Somatropin
Study Arms / Comparison Groups
Somatropin
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
98
Start Date
January 2005
Completion Date
December 2014
Primary Completion Date
December 2014
Eligibility Criteria
Inclusion Criteria:
- Glucocorticosteroid treatment for 12 months at least
- Bone age < 15 years for a boy and < 13 years for a girl
- Child measured height < - 2 SD, Child currently treated by GH
Exclusion Criteria:
- Known diabetes (type 1 or type 2)
- A previous history of intolerance or hypersensitivity to the study drug or to drugs
with similar chemical structures
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00163189
Organization ID
A6281271
Secondary IDs
2004-002992-17
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
June 2015