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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01543880
First received: February 28, 2012
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

This study is conducted in Europe. The aim of this 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:

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 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 ]

Estimated Enrollment: 427
Study Start Date: July 2003
Estimated Study Completion Date: December 2013
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543880

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: NCT01543880     History of Changes
Other Study ID Numbers: GH-1931
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, 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 May 23, 2013