NCT01502124

Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency

Norditropin® and Norditropin® Cartridges: An Open-Label, Randomized, Comparative Safety and Efficacy Trial in Children With Growth Hormone Deficiency

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Growth Hormone Disorder
• Growth Hormone Deficiency in Children

Interventions

Type	Name	Description
DRUG	somatropin	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
DRUG	somatropin	Injected subcutaneously 7 times per week. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists

Timeline

• Start date: 2001-05-08
• Primary completion: 2003-03-05
• Completion: 2003-03-05
• First posted: 2011-12-30
• Last updated: 2017-02-28

Locations

21 sites across 1 country: United States