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Safety and Efficacy of Long-term Somatropin Treatment in Adults (NordiWIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01543880
First received: February 28, 2012
Last updated: April 28, 2015
Last verified: April 2015

February 28, 2012
April 28, 2015
July 2003
December 2013   (final data collection date for primary outcome measure)
Number of adverse events [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01543880 on ClinicalTrials.gov Archive Site
  • BMI (Body Mass Index) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • HbA1c change [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • IGF-I (Insulin-Like Growth Factor I) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Number of patients with carcinoma [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Number of patients with diabetes mellitus [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Co-morbidities associated with growth hormone deficiency [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Long-term Somatropin Treatment in Adults
Non-interventional Study of Safety and Efficacy of Long-term Somatropin Treatment in Adults
This study is conducted in Europe. The aim of the study is to evaluate safety and efficacy in adults treated with somatropin (Norditropin®).
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample
Adults in need of somatropin or current users
  • Growth Hormone Disorder
  • Adult Growth Hormone Deficiency
Drug: somatropin
Prescribed at the discretion of the treating physician according to product labelling
Users of somatropin
Intervention: Drug: somatropin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
752
June 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • In need of somatropin or current user
Both
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01543880
GH-1931
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP