Infant, Small for Gestational Age
Conditions
Brief summary
A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin® in short children born small for gestational age.
Interventions
DRUGDA-3002
DRUGGenotropin®
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Chronological Age ≥ 4 * Before the adolescence, Tuner stage I (breast) * Height \<3rd percentile for age * Normal thyroid function
Exclusion criteria
* Growth hormone was administered for 12 months or longer in the past * Treated with estrogen or adrenal androgens for 12 months or longer in the past * Malignancy, CNS Trauma, Psychiatric Disorder * endocrine and/or metabolic disorders * growth failure caused by other disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized height velocity(cm/year) after 52 weeks. | 52 weeks | Height velocity calculated with height measured at Baseline and after 52 weeks was converted to annual growth rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in IGFBP-3 after 52 weeks | 52 weeks | — |
| Annualized height velocity(cm/year) after 26 weeks. | 26 weeks | Height velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate. |
| Changes in bone maturation(changes in bone ages/changes in chronological age) after 52 weeks | 52 weeks | — |
| Changes in IGF-1 after 52 weeks | 52 weeks | — |
| Changes in height standard deviation score after 52 weeks | 52 weeks | — |
Other
| Measure | Time frame |
|---|---|
| Changes in anti-growth hormone antibody | 52 weeks |
Countries
South Korea
Outcome results
None listed