A Clinical Study to Assess the Efficacy and Safety of DA-3002
Information source: Dong-A ST Co., Ltd.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Turner's Syndrome
Intervention: DA-3002 (Drug); Genotropin® (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Dong-A ST Co., Ltd. Official(s) and/or principal investigator(s): Han Wook Yoo, M.D., Ph.D., Principal Investigator, Affiliation: Asan Medical Center Byung Kyu Suh, M.D., Ph.D., Principal Investigator, Affiliation: Seoul St. Mary's Hospital, The Catholic University of Korea Cheol Woo Ko, M.D., Ph.D., Principal Investigator, Affiliation: Kyungpook National University Kee Hyoung Lee, M.D., Ph.D., Principal Investigator, Affiliation: Korea University Anam Hospital Dong Kyu Jin, M.D.,Ph.D., Principal Investigator, Affiliation: Seoul Medical Center Choong Ho Shin, M.D., Ph.D., Principal Investigator, Affiliation: Seoul National University Hospital Jin Soon Hwang, M.D., Ph.D., Principal Investigator, Affiliation: Aju University Hospital Ho Seong Kim, M.D., Ph.D., Principal Investigator, Affiliation: Severance Children's Hospital Yonsei University Woo Young Jeong, M.D., Ph.D., Principal Investigator, Affiliation: Pusan University Hospital Chang Jong Kim, M.D., Ph.D., Principal Investigator, Affiliation: Chonnam National University Hospital Heon Suk Han, M.D., Ph.D., Principal Investigator, Affiliation: Chungbuk National University Hospital
Overall contact: Dong Kyu Jin, M.D., Ph.D., Phone: 82-2-1599-3114
Summary
A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.
Clinical Details
Official title: Phase III Clinical Trial for Assessment of Efficacy and Safety of DA-3002 (Recombinant Human Growth Hormone) in Patients With Turner's Syndrome
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: A comparison of annualized height velocity between the DA-3002 treated group and the Genotropin® treated group after 52 weeks
Secondary outcome: A difference of Height Standard Deviation Score between the DA treated group and the Genotropin® treated group after 52 weeks
Eligibility
Minimum age: 2 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosed with Turner's Syndrome through chromosome analysis
- The chronological age: 2≤AGE≤12
- The yearly growth rate should be less than 6cm; the bone age should be equal or less
than 12; the height ≤ 10th percentile for the heights of their agemates
- Before the adolescence, Tuner stage I (breast)
- Normal thyroid function
Exclusion Criteria:
- Growth hormone was administered for 12 months or longer in the past
- Treated with estrogen or adrenal androgens for 12 months or longer in the past
- Malignancy, CNS Trauma, Psychiatric Disorder
Locations and Contacts
Dong Kyu Jin, M.D., Ph.D., Phone: 82-2-1599-3114
Samsung Medical Center, Seoul, Korea, Republic of; Recruiting Jin Dong Kyu, M.D., Ph.D., Phone: 82-2-1599-3114
Additional Information
Starting date: February 2013
Last updated: August 12, 2013
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