Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature
- Registration Number
- NCT01786902
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
Growth hormone therapy will improve the height of idiopathic short statured children. DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to non-treatment group in efficacy and safety.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- Chronological Age ≥ 4
- Bone Age <11 (for girls) and <13 (for boys)
- Height <3rd percentile for age
- normal thyroid function
Exclusion Criteria
- endocrine and/or metabolic disorders
- growth failure caused by other disorders
- previous use of drugs that could interfere with Growth Hormone treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DA-3002 Treatment group DA-3002 1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Changes in Height Standard Deviation Score After 26 Weeks 26 weeks The Height Standard Deviation Score was calculated as height minus reference mean height divided by the standard deviation of the reference mean height, both given by a reference growth table for the corresponding chronological age at the height measurement. Greater Height Standard Deviation Score indicates greater height.