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

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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.

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.

Condition or disease Intervention/treatment Phase
Idiopathic Short Stature Drug: DA-3002 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dwarfism Hormones
Drug Information available for: Somatropin
U.S. FDA Resources

Arm Intervention/treatment
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)
Drug: DA-3002
Other Name: Recombinant Human Growth Hormone
No Intervention: Non-treatment control group
Height be measured with no treatment



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Changes in Anti-growth Hormone Antibody [ Time Frame: baseline and 26 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01786902


Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
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
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

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01786902     History of Changes
Other Study ID Numbers: DA3002_ISS_III
First Posted: February 8, 2013    Key Record Dates
Results First Posted: May 29, 2015
Last Update Posted: October 19, 2017
Last Verified: September 2017

Keywords provided by Dong-A ST Co., Ltd.:
growth hormone

Additional relevant MeSH terms:
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs