Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Growth hormone therapy will improve the height of idiopathic short statured children. DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to non-treatment group in efficacy and safety.

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

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Hormones

Criteria

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