Safety and Efficacy of Long-term Somatropin Treatment in Adults

Adult Growth Hormone Deficiency Clinical Trial

— NordiWIN  

Official title:

Non-interventional Study of Safety and Efficacy of Long-term Somatropin Treatment in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543880
• Other study ID #: GH-1931
• Status: Completed
• Phase: N/A
• First received: February 28, 2012
• Last updated: April 28, 2015
• Start date: July 2003
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 752
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• In need of somatropin or current user

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Growth Hormone Disorder

Intervention

Drug:
• somatropin
Prescribed at the discretion of the treating physician according to product labelling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events		Up to 10 years	No
Secondary	BMI (Body Mass Index)		Up to 10 years	No
Secondary	HbA1c change		Up to 10 years	No
Secondary	IGF-I (Insulin-Like Growth Factor I)		Up to 10 years	No

External Links

•   Clinical Trials at Novo Nordisk