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OpenTrials
Completed

NCT Number: NCT01786902

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

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.

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Key information

Conditions

Idiopathic Short Stature

Age range

4 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-3002

Drug

Other names: Recombinant Human Growth Hormone

Primary outcomes

  1. Annualized Height Velocity(cm/Year) After 26 Weeks

    Time frame: 26 weeks

    Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.

Secondary outcomes

  1. Changes in Height Standard Deviation Score After 26 Weeks

    Time frame: 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.

Other outcomes

  1. Changes in Anti-growth Hormone Antibody

    Time frame: baseline and 26 weeks

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 8, 2013
Registry last updated
Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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