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

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ClinicalTrials.gov Identifier: NCT01543867
Recruitment Status : Completed
First Posted : March 5, 2012
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
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 Design

Study Type : Observational
Actual Enrollment : 5442 participants
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)
Study Start Date : January 2001
Primary Completion Date : December 2011
Study Completion Date : December 2011


Groups and Cohorts

Group/Cohort Intervention/treatment
Users of somatropin Drug: somatropin
Prescribed at the discretion of the treating physician according to product labelling


Outcome Measures

Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: Up to 10 years ]

Secondary Outcome Measures :
  1. Number of patients continuing somatropin treatment [ Time Frame: Up to 10 years ]
  2. Change in height [ Time Frame: Up to 10 years ]
  3. Onset of puberty in children small for gestational age [ Time Frame: Up to 10 years ]
  4. Co-morbidities in children small for gestational age [ Time Frame: Up to 10 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01543867


Locations
Germany
Mainz, Germany, 55127
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01543867     History of Changes
Other Study ID Numbers: GH-1930
First Posted: March 5, 2012    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Disease
Dwarfism, Pituitary
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Dwarfism
Growth Disorders
Genetic Diseases, Inborn
Pathologic Processes
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
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