Clinical Trial: Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Multicentre, Open Label, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Child Patients With GHD or Turner Short Stature Without Closure of
Brief Summary: This study is conducted in Japan. The aim of this study is to collect information about the efficacy and safety of Norditropin® (somatropin) in the long-term treatment of short stature with GHD (Growth Hormone Deficiency) where epiphysial discs are not closed and short stature with Turner Syndrome where epiphysial discs are not closed.
Detailed Summary:
Sponsor: Novo Nordisk A/S
Current Primary Outcome:
- Change from baseline in height [ Time Frame: Week 0, Month 36, final height is reached ]
- Incidence of adverse reactions (ADRs) [ Time Frame: 36 months, accumulation of study period ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Novo Nordisk A/S
Dates:
Date Received: May 21, 2012
Date Started: May 2005
Date Completion:
Last Updated: July 2, 2015
Last Verified: July 2015
