Safety and Efficacy of Long-term Somatropin Treatment in Children

Completed

• Conditions: Growth Hormone Deficiency in Children; Small for Gestational Age; Turner Syndrome; Growth Hormone Disorder; Foetal Growth Problem; Genetic Disorder; Growth Disorder; Idiopathic Short Stature
• Interventions: Drug: somatropin

• Registration Number: NCT01543867
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height. A subgroup of children small for their gestational age is included.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-02-28
• Study First Posted: 2012-03-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-27
• Last Update Posted: 2015-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5442

Inclusion Criteria

• In need of somatropin or current user

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Users of somatropin	somatropin	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events	Up to 10 years

Secondary Outcome Measures

Name	Time	Method
Change in height	Up to 10 years
Co-morbidities in children small for gestational age	Up to 10 years
Onset of puberty in children small for gestational age	Up to 10 years
Number of patients continuing somatropin treatment	Up to 10 years