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

Dong-A ST

Status and phase: Completed; Phase 3

Conditions: Turner's Syndrome

Treatments: Drug: Genotropin®; Drug: DA-3002

Study type: Interventional

Funder types: Industry

Identifiers

NCT01813630

DA3002_TS_III

Details and patient eligibility

About

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

Enrollment: 58 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

DA-3002

Experimental group

Description:

0.14 IU (0.045-0.050mg)/kg/day of DA-3002 is injected for 52 weeks by changing injecting areas

Treatment:

Drug: DA-3002

Genotropin®

Active Comparator group

Description:

0.14 IU (0.045-0.050mg)/kg/day of Genotropin is injected for 52 weeks by changing injecting areas

Treatment:

Drug: Genotropin®