CompletedPhase 3

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

South Korea75 participantsStarted 2016-02-26

Plain-language summary

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

Who can participate

Age range4 Years – 16 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 * 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

What they're measuring

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

Timeframe: 52 weeks

Trial details

NCT IDNCT02770157

SponsorDong-A ST Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-08-28

View on ClinicalTrials.gov More Infant, Small for Gestational Age trials