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

Phase III Clinical Trial for Assessment of Efficacy and Safety of DA-3002 (Recombinant Human Growth Hormone) in Short Children Born Small for Gestational Age.

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

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