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Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-3002 Treatment in Children with Idiopathic Short Stature

Not Applicable
Active, not recruiting
Conditions
Endocrine, nutritional and metabolic disease
Registration Number
KCT0000896
Lead Sponsor
Dong-A ST
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
All
Target Recruitment
64
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

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The difference of annualized height velocity between treatment group and non-treatment group after 26 weeks
Secondary Outcome Measures
NameTimeMethod
Difference of Height Standard Deviation Score between treatment and non-treatment group after 26 weeks
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