Idiopathic Short Stature Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01786902
First received: February 6, 2013
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Idiopathic Short Stature
Drug: DA-3002
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dong-A ST Co., Ltd.:

Primary Outcome Measures:
  • The difference of annualized height velocity between treatment group and non-treatment group after 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference of Height Standard Deviation Score between treatment and non-treatment group after 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • The change of antibodies to growth hormone [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: February 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Years to 13 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01786902     History of Changes
Other Study ID Numbers: DA3002_ISS_III
Study First Received: February 6, 2013
Last Updated: August 12, 2013
Health Authority: South Korea : Korea Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 23, 2014