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Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature

NCT01786902 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-10-19

Study results available
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Summary

Growth hormone therapy will improve the height of idiopathic short statured children. DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to non-treatment group in efficacy and safety.

Conditions

  • Idiopathic Short Stature

Interventions

DRUG

DA-3002

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hanwook Yoo, MD · Asan Medical Center

  • Byungkyu Suh, MD · Seoul St. Mary's Hospital

  • Cheolwoo Ko, MD · Kyungpook National University Hospital

  • Keehyoung Lee, MD · Korea University Anam Hospitial

  • Dongkyu Jin, MD · Samsung Medical Center

  • Choongho Shin, MD · Seoul National University Hospital

  • Jinsoon Hwang, MD · Aju University Hospital

  • Hoseong Kim, MD · Severance Children's Hospital Yonsei University

  • Wooyoung Jeong, MD · Pusan University Hospital

  • Chanjong Kim, MD · Chonnam National University Hospital

  • Heonsuk Han, MD · Chungbuk National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-04-30
Completion
2014-04-30

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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 NCT01786902 on ClinicalTrials.gov