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

Idiopathic Short Stature Clinical Trial

Official title:

Open, Multi-Center, Controlled, Randomized Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-3002(Recombinant Humn Growth Hormone)Treatment in Children With Idiopathic Short Stature

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786902
• Other study ID #: DA3002_ISS_III
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2013
• Last updated: September 18, 2017
• Start date: February 2012
• Est. completion date: April 2014

Study information

• Verified date: September 2017
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Dwarfism
• Idiopathic Short Stature

Intervention

Drug:
• DA-3002

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Anti-growth Hormone Antibody		baseline and 26 weeks
Primary	Annualized Height Velocity(cm/Year) After 26 Weeks	Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.	26 weeks
Secondary	Changes in Height Standard Deviation Score After 26 Weeks	The Height Standard Deviation Score was calculated as height minus reference mean height divided by the standard deviation of the reference mean height, both given by a reference growth table for the corresponding chronological age at the height measurement. Greater Height Standard Deviation Score indicates greater height.	26 weeks