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Safety and Efficacy of Long-term Somatropin Treatment in Children

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Growth Hormone Disorder; Growth Hormone Deficiency in Children; Foetal Growth Problem; Small for Gestational Age; Genetic Disorder; Turner Syndrome; Growth Disorder; Idiopathic Short Stature

Intervention: somatropin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S


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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome: Number of adverse events

Secondary outcome:

Number of patients continuing somatropin treatment

Change in height

Onset of puberty in children small for gestational age

Co-morbidities in children small for gestational age


Minimum age: N/A. Maximum age: 18 Years. Gender(s): Both.


Inclusion Criteria:

- In need of somatropin or current user

Locations and Contacts

Mainz 55127, Germany
Additional Information

Clinical Trials at Novo Nordisk

Starting date: January 2001
Last updated: March 27, 2015

Page last updated: August 23, 2015

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