Efficacy and Safety of DA-3002 in Short Children Borns SGA.
NCT ID: NCT02770157
Last Updated: 2019-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
75 participants
INTERVENTIONAL
2016-02-26
2019-08-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DA-3002
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).
DA-3002
Genotropin®
1.44 IU (0.48mg)/kg/week of Genotropin is injected for 52 weeks by changing injecting areas(six or seven times per week).
Genotropin®
Non-treatment control group
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).
DA-3002
Interventions
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DA-3002
Genotropin®
Eligibility Criteria
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Inclusion Criteria
* Before the adolescence, Tuner stage I (breast)
* Height \<3rd percentile for age
* Normal thyroid function
Exclusion Criteria
* 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
4 Years
16 Years
ALL
No
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Dong kyu Jin, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul Samsung Medical center.
Byung Kyu Suh, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Mary's Hospital, The Catholic University of Korea
Cheol Woo Ko, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Kyungpook National University Hospital
Kee Hyoung Lee, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Korea University Anam Hospital
Han Wook Yoo, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Choong Ho Shin, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Jin Soon Hwang, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Aju University Hospital
Ho Seong Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Severance Children's Hospital Yonsei University
Woo Young Jeong, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Pusan University Hospital
Chang Jong Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chonnam National University Hospital
Heon Suk Han, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chungbuk National University Hospital
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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References
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Kim SJ, Kim MS, Cho SY, Suh BK, Ko CW, Lee KH, Yoo HW, Shin CH, Hwang JS, Kim HS, Chung WY, Kim CJ, Han HS, Jin DK. Efficacy and safety of the recombinant human growth hormone in short children born small for gestational age: A randomized, multicentre, comparative phase III trial. Medicine (Baltimore). 2021 Jul 30;100(30):e26711. doi: 10.1097/MD.0000000000026711.
Other Identifiers
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DA3002_SGA_III
Identifier Type: -
Identifier Source: org_study_id
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