Observational Study of the Safety and Efficacy of Norditropin® in Patients With SGA (Small for Gestational Age) Short Stature That Are Still Growing
This trial is active, not recruiting.
|Conditions||foetal growth problem, small for gestational age|
|Sponsor||Novo Nordisk A/S|
|Start date||November 2009|
|End date||October 2018|
|Trial size||360 participants|
|Trial identifier||NCT01110928, GH-3812, JapicCTI-101123, U1111-1114-6280|
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).
Number and type of suspected serious adverse drug reactions (SADRs) during the study period
time frame: evaluated binannually for 9 years
Number of glucose intolerance events during the study period
time frame: evaluated biannually for 9 years
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
Male or female participants of any age.
Inclusion Criteria: - Participation in the GHLIQUID-1517 trial - Patients with SGA (small for gestational age) short stature that are still growing Exclusion Criteria: - Known or suspected allergy to study product(s) or related products - Diabetes Mellitus - Patients with malignant tumor(s) - Pregnant or likely to get pregnant
|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|
Call for more information