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 ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Novo Nordisk A/S
First received: April 19, 2010
Last updated: September 12, 2014
Last verified: September 2014
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).
Foetal Growth Problem
Small for Gestational Age
||Observational Model: Cohort
Time Perspective: Prospective
||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
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| 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.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients with SGA short stature that are still growing, who will either receive Norditropin® (somatropin) treatment or completed the GHLIQUID-1517 trial.
- Participation in the GHLIQUID-1517 trial
- Patients with SGA (small for gestational age) short stature that are still growing
- Known or suspected allergy to study product(s) or related products
- Diabetes Mellitus
- Patients with malignant tumor(s)
- Pregnant or likely to get pregnant
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01110928
Novo Nordisk A/S
||Novo Nordisk Pharma Ltd.
No publications provided
||Novo Nordisk A/S
History of Changes
|Other Study ID Numbers:
||GH-3812, U1111-1114-6280, JapicCTI-101123
|Study First Received:
||April 19, 2010
||September 12, 2014
||Japan: Pharmaceuticals and Medical Devices Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 29, 2014
Bone Diseases, Developmental
Genetic Diseases, Inborn
Endocrine System Diseases