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

Last updated: January 12, 2017
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

4

Condition

Nephropathy

Metachromatic Leukodystrophy - Mld

Hypogonadism

Treatment

N/A

Clinical Study ID

NCT01245374
GH-3826
2009-017387-16
U1111-1117-1194
  • Ages > 6
  • All Genders

Study 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

Inclusion Criteria:

  • Children who can receive Norditropin® (somatropin) treatment according to the productlabelling

  • Treated with growth hormone for at least one year

Exclusion

Exclusion Criteria:

  • 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 studystart

  • Life threatening disease, for example cancer

  • Pregnancy or the intention of becoming pregnant

Study Design

Total Participants: 103
Study Start date:
November 01, 2010
Estimated Completion Date:
April 30, 2011

Connect with a study center

  • empty

    Paris La défense cedex, 92936
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Paris La défense cedex, 92932
    France

    Site Not Available

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