Clinical Trial: Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton®
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational
Official Title: Non-interventional, Observational Study of the Application of Zomacton® in the Treatment of Growth Hormone Deficiency in Routine Clinical Practice
Brief Summary: The purpose of this study is to investigate the long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner's syndrome.
Detailed Summary:
Sponsor: Ferring Pharmaceuticals
Current Primary Outcome: Efficacy of Zomacton® treatment measured by the increase in body height per annuum [ Time Frame: 5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Efficacy of Zomacton® treatment measured by the increase in body weight per annuum [ Time Frame: 5 years ]
- Safety of Zomacton® and the application device measured by local adverse reactions to the application device [ Time Frame: 5 years ]
Original Secondary Outcome: Same as current
Information By: Ferring Pharmaceuticals
Dates:
Date Received: November 16, 2012
Date Started: January 2013
Date Completion: June 2018
Last Updated: January 31, 2013
Last Verified: January 2013
