Completed
PHASE3
INTERVENTIONAL
NCT01502124
Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency
View on ClinicalTrials.gov
Updated Dec 15, 2025
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 somatropin) in children with growth hormone deficiency.
Interventions
Name:
somatropin
Type:
DRUG
Description:
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
Name:
somatropin
Type:
DRUG
Description:
Injected subcutaneously 7 times per week. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists
Primary Outcomes
Measure:
Adverse events (especially injection site reactions)
TimeFrame:
Description:
Measure:
Serious adverse events
TimeFrame:
Description:
Trial Information
NCT ID
NCT01502124
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Novo Nordisk A/S
Last Updated
December 15, 2025