Efficacy and Safety of DA-3002 in Short Children Borns SGA.
Phase 3
Completed
- Conditions
- Infant, Small for Gestational Age
- Interventions
- Registration Number
- NCT02770157
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin® in short children born small for gestational age.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DA-3002 DA-3002 1.44 IU (0.48mg)/kg/week of DA-3002 is injected for 52 weeks by changing injecting areas(six or seven times per week). Genotropin® Genotropin® 1.44 IU (0.48mg)/kg/week of Genotropin is injected for 52 weeks by changing injecting areas(six or seven times per week). Non-treatment control group DA-3002 After no treatment for 26 weeks, 1.44 IU (0.48mg)/kg/week of DA-3002 is injected for 52 weeks by changing injecting areas(six or seven times per week).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Changes in IGF-1 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 height standard deviation score after 52 weeks 52 weeks Changes in bone maturation(changes in bone ages/changes in chronological age) after 52 weeks 52 weeks Changes in IGFBP-3 after 52 weeks 52 weeks
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center🇰🇷Seoul, Korea, Republic of