Foetal Growth Problem, Small for Gestational Age
Conditions
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).
Interventions
DRUGsomatropin
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.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and type of suspected serious adverse drug reactions (SADRs) during the study period | evaluated binannually for 9 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Outcome results
None listed