Phase 3
N=70
Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature
Idiopathic Short Stature
Bottom Line
View on ClinicalTrials.gov: NCT01786902 ↗Enrolled (actual)
70
Serious AEs
3.0%
Results posted
May 2015
Primary outcome: Primary: Annualized Height Velocity(cm/Year) After 26 Weeks — 10.68; 5.72 cm/year
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DA-3002 (Drug)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Dong-A ST Co., Ltd.
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Height Velocity(cm/Year) After 26 Weeks |
10.68; 5.72 | — |
| SECONDARY Changes in Height Standard Deviation Score After 26 Weeks |
0.63; 0.06 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01786902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.