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

Dong-A ST

Status and phase: Completed; Phase 3

Conditions: Idiopathic Short Stature

Treatments: Drug: DA-3002

Study type: Interventional

Funder types: Industry

Identifiers

NCT01786902

DA3002_ISS_III

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 4 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

DA-3002 Treatment group

Experimental group

Description:

1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)

Treatment:

Drug: DA-3002

Non-treatment control group

No Intervention group

Description:

Height be measured with no treatment