Status:

COMPLETED

Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Growth Hormone Disorder

Growth Hormone Deficiency in Children

Eligibility:

All Genders

6+ years

Phase:

PHASE4

Brief Summary

This study is conducted in Europe. The aim of this study is to compare the easiness of use of Norditropin NordiFlex® device to the device previously used by patients or parents.

Eligibility Criteria

Inclusion

  • Children who can receive Norditropin® (somatropin) treatment according to the product labelling
  • Treated with growth hormone for at least one year

Exclusion

  • Contraindications to Norditropin® growth hormone therapy
  • Known or suspected hypersensitivity to somatropin or related products
  • The receipt of any investigational medicinal product within 3 months prior to study start
  • Life threatening disease, for example cancer
  • Pregnancy or the intention of becoming pregnant

Key Trial Info

Start Date :

November 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2011

Estimated Enrollment :

103 Patients enrolled

Trial Details

Trial ID

NCT01245374

Start Date

November 1 2010

End Date

April 1 2011

Last Update

February 27 2017

Active Locations (1)

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1

Novo Nordisk Investigational Site

Paris La Défense Cedex, France, 92932