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

Dong-A ST Co., Ltd.70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Idiopathic Short Stature

Interventions

DA-3002DRUG

Eligibility

Sex: ALLMin age: 4 YearsMax age: 13 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Annualized Height Velocity(cm/Year) After 26 Weeks

Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.

Time frame: 26 weeks

Secondary Outcomes

Changes in Height Standard Deviation Score After 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.

Time frame: 26 weeks

Data from ClinicalTrials.gov

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