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
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.
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 treatmentChange in height Onset of puberty in children small for gestational age Co-morbidities in children small for gestational age
Eligibility
Minimum age: N/A.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
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
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