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

NCT02770157 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2019-10-16

No results posted yet for this study

Summary

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

Conditions

  • Infant, Small for Gestational Age

Interventions

DRUG

DA-3002

DRUG

Genotropin®

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Dong kyu Jin, M.D., Ph.D. · Seoul Samsung Medical center.

  • Byung Kyu Suh, M.D., Ph.D. · Seoul St. Mary's Hospital, The Catholic University of Korea

  • Cheol Woo Ko, M.D., Ph.D. · Kyungpook National University Hospital

  • Kee Hyoung Lee, M.D., Ph.D. · Korea University Anam Hospital

  • Han Wook Yoo, M.D., Ph.D. · Asan Medical Center

  • Choong Ho Shin, M.D., Ph.D. · Seoul National University Hospital

  • Jin Soon Hwang, M.D., Ph.D. · Aju University Hospital

  • Ho Seong Kim, M.D., Ph.D. · Severance Children's Hospital Yonsei University

  • Woo Young Jeong, M.D., Ph.D. · Pusan University Hospital

  • Chang Jong Kim, M.D., Ph.D. · Chonnam National University Hospital

  • Heon Suk Han, M.D., Ph.D. · Chungbuk National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-26
Primary Completion
2019-08-28
Completion
2019-08-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02770157 on ClinicalTrials.gov