This trial is active, not recruiting.

Condition idiopathic short stature
Treatment da-3002
Phase phase 3
Sponsor Dong-A Pharmaceutical Co., Ltd.
Start date February 2011
End date April 2014
Trial size 70 participants
Trial identifier NCT01786902, DA3002_ISS_III


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)
da-3002 Recombinant Human Growth Hormone
(No Intervention)
Height be measured with no treatment

Primary Outcomes

The difference of annualized height velocity between treatment group and non-treatment group after 26 weeks
time frame: 26 weeks

Secondary Outcomes

Difference of Height Standard Deviation Score between treatment and non-treatment group after 26 weeks
time frame: 26 weeks

Eligibility Criteria

Male or female participants from 4 years up to 13 years old.

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

Additional Information

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
Principal investigator Hanwook Yoo, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Dong-A Pharmaceutical Co., Ltd..