Status:
COMPLETED
Effect of Growth Hormone in Children With Growth Hormone Deficiency
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Growth Hormone Disorder
Growth Hormone Deficiency in Children
Eligibility:
All Genders
3-15 years
Phase:
PHASE3
Brief Summary
This trial is conducted in the United States of America (USA). The purpose of the trial is to compare the effect of Norditropin® using different dosing regimens in children suspected of growth hormone...
Eligibility Criteria
Inclusion
- Clinically suspected GHD
- Height \< -2.0 SDS
- Serum IGF-I less than or equal to -1.0 SDS
- Bone age less than or equal to 9 years for boys and less than or equal to 7 years for girls.
- Puberty Tanner Stage I
Exclusion
- Previous use of growth hormone
- Growth retardation attributable to causes other than GHD (e.g. inborn errors of metabolism, primary bone disease, chromosomal disorders, etc.)
- Intrauterine growth retardation: birth weight \< 3rd percentile.
- Administration of other growth-altering medications.
- Evidence of any malignancy or intracranial tumors.
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT00262249
Start Date
August 1 2000
End Date
May 1 2004
Last Update
January 18 2017
Active Locations (40)
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1
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90027
2
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90095
3
Novo Nordisk Investigational Site
Sacramento, California, United States, 95817
4
Novo Nordisk Investigational Site
San Diego, California, United States, 92093