CompletedPhase 3

Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature

70 participantsStarted 2012-02

Plain-language 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.

Who can participate

Age range4 Years – 13 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Annualized Height Velocity(cm/Year) After 26 Weeks

Timeframe: 26 weeks

Trial details

NCT IDNCT01786902

SponsorDong-A ST Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-04

Results submitted2014-11-20

View on ClinicalTrials.gov More Idiopathic Short Stature trials