Overview

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

Status:
Completed
Trial end date:
2019-08-28
Target enrollment:
0
Participant gender:
All
Summary
A study demonstrates the non-inferiority of DA-3002 when compared with GenotropinĀ® in short children born small for gestational age.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dong-A ST Co., Ltd.
Criteria
Inclusion Criteria:

- Chronological Age ā‰„ 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