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 somatropin) in children with growth hormone deficiency.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Injected subcutaneously 7 times per week after reconstitution with liquid buffer prior to use. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists
Injected subcutaneously 7 times per week. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists
Novo Nordisk Investigational Site
Los Angeles, California, United States
Adverse events (especially injection site reactions)
Serious adverse events
IGF-1 (Insulin-like growth factor 1) concentration
IGFBP-3 (Insulin-like growth factor binding protein 3) concentration
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Novo Nordisk Investigational Site
Los Angeles, California, United States
Novo Nordisk Investigational Site
Wilmington, Delaware, United States
Novo Nordisk Investigational Site
Washington D.C., District of Columbia, United States
Novo Nordisk Investigational Site
Gainesville, Florida, United States
Novo Nordisk Investigational Site
Miami, Florida, United States
Novo Nordisk Investigational Site
Orlando, Florida, United States
Novo Nordisk Investigational Site
Tampa, Florida, United States
Novo Nordisk Investigational Site
Atlanta, Georgia, United States
Novo Nordisk Investigational Site
Chicago, Illinois, United States
...and 11 more locations