Safety and Efficacy of Long-term Somatropin Treatment in Children

Non-interventional Study of the Safety and Efficacy of Long-term Somatropin Treatment in Children (GrowthWIN II / GrowthWIN II SGA)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01543867

Acronym

GrowthWIN II

Enrollment

5442

Registered

2012-03-05

Start date

2001-01-31

Completion date

2011-12-31

Last updated

2015-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foetal Growth Problem, Genetic Disorder, Growth Disorder, Growth Hormone Deficiency in Children, Growth Hormone Disorder, Idiopathic Short Stature, Small for Gestational Age, Turner Syndrome

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.

Interventions

DRUGsomatropin

Prescribed at the discretion of the treating physician according to product labelling

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

Inclusion criteria

* In need of somatropin or current user

Design outcomes

Primary

Measure	Time frame
Number of adverse events	Up to 10 years

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026