Status:
COMPLETED
Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Growth Hormone Disorder
Growth Hormone Deficiency in Children
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
Brief Summary
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety profiles of Norditropin® (lyophilized somatropin) and Norditropin® cartridges (liquid som...
Eligibility Criteria
Inclusion
- Diagnosis of short stature (height maximum 2 standard deviations of mean for age and gender) or inadequate growth deemed secondary to growth hormone deficiency (GHD)
- Naïve to growth hormone therapy
Exclusion
- Known or suspected allergy to the trial product or related products
- Growth retardation attributable to causes other than GHD. Growth retardation attributable to diabetes mellitus, inborn errors of metabolism, primary bone disease, chromosomal disorders or disease of the genitourinary, cardiopulmonary, gastrointestinal or central nervous system; bone marrow transplantation or any syndrome known to give short stature (examples are: Prader-Willi Syndrome, Russell-Silver Syndrome, Turner Syndrome, Noonan Syndrome)
- Intrauterine growth retardation: birth weight below 3rd percentile, adjusted for gestational age
- Pregnancy or the intention to become pregnant
- Breast-feeding
- Administration of other growth-altering medication
Key Trial Info
Start Date :
May 8 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2003
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01502124
Start Date
May 8 2001
End Date
March 5 2003
Last Update
February 28 2017
Active Locations (21)
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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, 90048-1869
3
Novo Nordisk Investigational Site
Wilmington, Delaware, United States, 19899
4
Novo Nordisk Investigational Site
Washington D.C., District of Columbia, United States, 20010