Observational Study of the Safety and Efficacy of Norditropin® in Patients With SGA (Small for Gestational Age) Short Stature That Are Still Growing
- Registration Number
- NCT01110928
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 227
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Norditropin® somatropin -
- Primary Outcome Measures
Name Time Method Number and type of suspected serious adverse drug reactions (SADRs) during the study period evaluated binannually for 9 years
- Secondary Outcome Measures
Name Time Method Number of glucose intolerance events during the study period evaluated biannually for 9 years Adult height Fulfilment will be evaluated once a year. Height when closure of ephiphyseal discs exists or when accomplished adult height is confirmed by physician
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇯🇵Tokyo, Japan