Completed
SGAPhase III Clinical Trial for Assessment of Efficacy and Safety of DA-3002 (Recombinant Human Growth Hormone) in Short Children Born Small for Gestational Age.
What is being tested
DA-3002
+ Genotropin®
Drug
Who is being recruted
From 4 to 16 Years
+9 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: February 2016
Summary
Principal SponsorDong-A ST Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: February 26, 2016
Actual date on which the first participant was enrolled.A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin® in short children born small for gestational age.
Official TitlePhase III Clinical Trial for Assessment of Efficacy and Safety of DA-3002 (Recombinant Human Growth Hormone) in Short Children Born Small for Gestational Age.
Principal SponsorDong-A ST Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
75 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 4 to 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
4 inclusion criteria required to participate
Chronological Age ≥ 4
Before the adolescence, Tuner stage I (breast)
Height <3rd percentile for age
Normal thyroid function
5 exclusion criteria prevent from participating
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
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Experimental1.44 IU (0.48mg)/kg/week of DA-3002 is injected for 52 weeks by changing injecting areas(six or seven times per week).
Group II
After no treatment for 26 weeks, 1.44 IU (0.48mg)/kg/week of DA-3002 is injected for 52 weeks by changing injecting areas(six or seven times per week).
Group III
Active Comparator1.44 IU (0.48mg)/kg/week of Genotropin is injected for 52 weeks by changing injecting areas(six or seven times per week).
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center