Efficacy and Safety of DA-3002 in Short Children Borns SGA.

Dong-A ST Co., Ltd.75 enrolled

Overview

A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin® in short children born small for gestational age.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infant, Small for Gestational Age

Interventions

DA-3002DRUG

Genotropin®DRUG

Eligibility

Sex: ALLMin age: 4 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chronological Age ≥ 4 * Before the adolescence, Tuner stage I (breast) * Height \<3rd percentile for age * 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 * endocrine and/or metabolic disorders * growth failure caused by other disorders

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Annualized height velocity(cm/year) after 52 weeks.

Height velocity calculated with height measured at Baseline and after 52 weeks was converted to annual growth rate.

Time frame: 52 weeks

Secondary 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

Changes in height standard deviation score after 52 weeks

Time frame: 52 weeks

Changes in bone maturation(changes in bone ages/changes in chronological age) after 52 weeks

Time frame: 52 weeks

Changes in IGF-1 after 52 weeks

Time frame: 52 weeks

Changes in IGFBP-3 after 52 weeks

Time frame: 52 weeks

Data from ClinicalTrials.gov

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