Status:
COMPLETED
Growth Retardation In Children With Special Pathological Conditions Or Disease
Lead Sponsor:
Pfizer
Conditions:
Endocrine System Diseases
Eligibility:
All Genders
11-13 years
Phase:
PHASE3
Brief Summary
To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of GH treatment.
Eligibility Criteria
Inclusion
- Bone age \< 13 years for a boy and \< 11 years for a girl
- Naive child: Measured Height \< -2.5 SD for CA
- Child currently treated by GH
Exclusion
- Idiopathic short stature
- Syndrome known to be associated with an increased risk of cancer e.g. family history of adenomatous polyposis
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00163215
Start Date
January 1 2005
End Date
October 1 2011
Last Update
December 19 2012
Active Locations (18)
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1
Pfizer Investigational Site
Annemasse, France, 74107
2
Pfizer Investigational Site
Besançon, France, 25030
3
Pfizer Investigational Site
Bordeaux, France, 33000
4
Pfizer Investigational Site
Bordeaux, France, 33076