A Clinical Study to Assess the Efficacy and Safety of DA-3002

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

Summary

A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.; Dong-A ST Co., Ltd.

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