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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01543880
Other study ID # GH-1931
Secondary ID
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


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
See also
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