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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01543867
First received: February 28, 2012
Last updated: June 26, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Growth Hormone Disorder
Growth Hormone Deficiency in Children
Foetal Growth Problem
Small for Gestational Age
Genetic Disorder
Turner Syndrome
Growth Disorder
Idiopathic Short Stature
 Drug: somatropin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Non-interventional Study of the Safety and Efficacy of Long-term Somatropin Treatment in Children (GrowthWIN II / GrowthWIN II SGA)

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients continuing somatropin treatment [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Change in height [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Onset of puberty in children small for gestational age [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Co-morbidities in children small for gestational age [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Enrollment: 5233
Study Start Date: January 2001
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Users of somatropin Drug: somatropin
Prescribed at the discretion of the treating physician according to product labelling

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children treated with somatropin

Criteria

Inclusion Criteria:

  • In need of somatropin or current user
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543867

Locations
Germany
Mainz, Germany, 55127
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Medical director of the German affiliate Novo Nordisk Pharma GmbH
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01543867     History of Changes
Other Study ID Numbers: GH-1930
Study First Received: February 28, 2012
Last Updated: June 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Dwarfism
Dwarfism, Pituitary
Growth Disorders
Genetic Diseases, Inborn
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Gonadal Disorders

ClinicalTrials.gov processed this record on May 21, 2013