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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01786902
Recruitment Status : Completed
First Posted : February 8, 2013
Results First Posted : May 29, 2015
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Tracking Information
First Submitted Date  ICMJE February 6, 2013
First Posted Date  ICMJE February 8, 2013
Results First Submitted Date  ICMJE November 20, 2014
Results First Posted Date  ICMJE May 29, 2015
Last Update Posted Date October 19, 2017
Study Start Date  ICMJE February 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
Annualized Height Velocity(cm/Year) After 26 Weeks [ Time Frame: 26 weeks ]
Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2013)
The Difference of Annualized Height Velocity Between Treatment Group and Non-treatment Group After 26 Weeks [ Time Frame: 26 weeks ]
Change History Complete list of historical versions of study NCT01786902 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
Changes in Height Standard Deviation Score After 26 Weeks [ Time Frame: 26 weeks ]
The Height Standard Deviation Score was calculated as height minus reference mean height divided by the standard deviation of the reference mean height, both given by a reference growth table for the corresponding chronological age at the height measurement. Greater Height Standard Deviation Score indicates greater height.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2013)
Difference of Height Standard Deviation Score Between Treatment and Non-treatment Group After 26 Weeks [ Time Frame: 26 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: September 18, 2017)
Changes in Anti-growth Hormone Antibody [ Time Frame: baseline and 26 weeks ]
Original Other Pre-specified Outcome Measures
 (submitted: February 7, 2013)
The Change of Antibodies to Growth Hormone [ Time Frame: 26 weeks ]
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature
Official Title  ICMJE Open, Multi-Center, Controlled, Randomized Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-3002(Recombinant Humn Growth Hormone)Treatment in Children With Idiopathic Short Stature
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Short Stature
Intervention  ICMJE Drug: DA-3002
Other Name: Recombinant Human Growth Hormone
Study Arms  ICMJE
  • Experimental: DA-3002 Treatment group
    1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)
    Intervention: Drug: DA-3002
  • No Intervention: Non-treatment control group
    Height be measured with no treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2013)
70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chronological Age ≥ 4
  • Bone Age <11 (for girls) and <13 (for boys)
  • Height <3rd percentile for age
  • normal thyroid function

Exclusion Criteria:

  • endocrine and/or metabolic disorders
  • growth failure caused by other disorders
  • previous use of drugs that could interfere with Growth Hormone treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01786902
Other Study ID Numbers  ICMJE DA3002_ISS_III
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dong-A ST Co., Ltd.
Study Sponsor  ICMJE Dong-A ST Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hanwook Yoo, MD Asan Medical Center
Study Director: Byungkyu Suh, MD Seoul St. Mary's Hospital
Study Director: Cheolwoo Ko, MD Kyungpook National University Hospital
Study Director: Keehyoung Lee, MD Korea University Anam Hospitial
Study Director: Dongkyu Jin, MD Samsung Medical Center
Study Director: Choongho Shin, MD Seoul National University Hospital
Study Director: Jinsoon Hwang, MD Aju University Hospital
Study Director: Hoseong Kim, MD Severance Children's Hospital Yonsei University
Study Director: Wooyoung Jeong, MD Pusan University Hospital
Study Director: Chanjong Kim, MD Chonnam National University Hospital
Study Director: Heonsuk Han, MD Chungbuk National University Hospital
PRS Account Dong-A ST Co., Ltd.
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP