Observational Study of the Safety and Efficacy of Norditropin® in Patients With SGA (Small for Gestational Age) Short Stature That Are Still Growing
This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® in the long-term treatment of patients with a SGA (small for gestational age) short stature where the growth plate in the long bones (epiphyseal disc) is not closed. An extension to the GHLIQUID-1517 trial (NCT00184717).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Patients With SGA Short Stature Without Closure of Epiphyseal Discs|
- Number and type of suspected serious adverse drug reactions (SADRs) during the study period [ Time Frame: evaluated binannually for 9 years ] [ Designated as safety issue: Yes ]
- Number of glucose intolerance events during the study period [ Time Frame: evaluated biannually for 9 years ] [ Designated as safety issue: Yes ]
- Adult height [ Time Frame: Fulfilment will be evaluated once a year. Height when closure of ephiphyseal discs exists or when accomplished adult height is confirmed by physician ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||October 2018|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, at study initiation and every 6 months until last visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01110928
|Tokyo, Japan, 1000005|
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|