A Clinical Study to Assess the Efficacy and Safety of DA-3002
- Registration Number
- NCT01813630
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Inclusion Criteria
- Diagnosed with Turner's Syndrome through chromosome analysis
- The chronological age: 2≤AGE≤12
- The yearly growth rate should be less than 6cm; the bone age should be equal or less than 12; the height ≤ 10th percentile for the heights of their agemates
- Before the adolescence, Tuner stage I (breast)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DA-3002 DA-3002 0.14 IU (0.045-0.050mg)/kg/day of DA-3002 is injected for 52 weeks by changing injecting areas Genotropin® Genotropin® 0.14 IU (0.045-0.050mg)/kg/day of Genotropin is injected for 52 weeks by changing injecting areas
- 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 52 weeks Changes in height standard deviation score after 52 weeks 52 weeks Changes in bone maturation(changes in bone ages/changes in chronological age) 52 weeks Changes in IGFBP-3 52 weeks
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center🇰🇷Seoul, Korea, Republic of