Clinical Trial: Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTON

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Non-interventional Study With ZOMACTON in Children With Growth Hormone Deficiency

Brief Summary: The purpose of this study is to investigate long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner syndrome.

Detailed Summary:
Sponsor: Ferring Pharmaceuticals

Current Primary Outcome: Efficacy of ZOMACTON [ Time Frame: Up to 5 years ]

measured by: body height, increase of body height per annum


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Efficacy measured by further parameters [ Time Frame: Up to 5 years ]
    measured by: weight, increase weight per annum sitting height, increase of sitting height per annum head circumference per annum bone age, increase of bone age per annum puberty development IGF-1, IGFBP-3 psychological cofactors
  • Safety of Zomacton and application device [ Time Frame: Up to 5 years ]
    measured by: local adverse reactions to the application device adverse events of Zomacton safety laboratory


Original Secondary Outcome: Same as current

Information By: Ferring Pharmaceuticals

Dates:
Date Received: June 1, 2011
Date Started: November 2007
Date Completion:
Last Updated: September 21, 2016
Last Verified: September 2016