Status:
COMPLETED
A Clinical Study to Assess the Efficacy and Safety of DA-3002
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Turner's Syndrome
Eligibility:
All Genders
2-12 years
Phase:
PHASE3
Brief Summary
A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01813630
Start Date
February 1 2013
End Date
May 1 2018
Last Update
July 26 2018
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea