Safety and Efficacy of Long-term Somatropin Treatment in Children (GrowthWIN II)

Novo Nordisk

Status: Completed

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

Treatments: Drug: somatropin

Study type: Observational

Funder types: Industry

Identifiers

NCT01543867

GH-1930

Details and patient eligibility

About

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.

Enrollment: 5,442 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• In need of somatropin or current user

Trial design

5,442 participants in 1 patient group

Users of somatropin

Treatment:

Drug: somatropin