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: January 8, 2014
Last verified: January 2014
  Purpose

This study is conducted in Europe. The aim of the study is to evaluate safety and efficacy in adults treated with somatropin (Norditropin®).


Condition Intervention
Growth Hormone Disorder
Adult Growth Hormone Deficiency
Drug: somatropin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Non-interventional Study of Safety and Efficacy of Long-term Somatropin Treatment in Adults

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 752
Study Start Date: July 2003
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adults in need of somatropin or current users

Criteria

Inclusion Criteria:

  • In need of somatropin or current user
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543880

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

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01543880     History of Changes
Other Study ID Numbers: GH-1931
Study First Received: February 28, 2012
Last Updated: January 8, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014