Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome (NordiPAD)
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.
Growth Hormone Disorder
Growth Hormone Deficiency in Children
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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 Epiphyseal Discs|
- Change from baseline in height [ Time Frame: Week 0, Month 36, final height is reached ] [ Designated as safety issue: No ]
- Incidence of adverse reactions (ADRs) [ Time Frame: 36 months, accumulation of study period ] [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Collection of safety and efficacy data in connection with use of somatropin (Norditropin®) in daily clinical practice.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604161
|Tokyo, Japan, 1000005|
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|