MedDataX Logo

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

NCT ID: NCT01786902

Last Updated: 2017-10-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Idiopathic Short Stature

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

growth hormone

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DA-3002 Treatment group

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

Group Type EXPERIMENTAL

DA-3002

Intervention Type DRUG

Non-treatment control group

Height be measured with no treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DA-3002

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Recombinant Human Growth Hormone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

4 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hanwook Yoo, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Byungkyu Suh, MD

Role: STUDY_DIRECTOR

Seoul St. Mary's Hospital

Cheolwoo Ko, MD

Role: STUDY_DIRECTOR

Kyungpook National University Hospital

Keehyoung Lee, MD

Role: STUDY_DIRECTOR

Korea University Anam Hospitial

Dongkyu Jin, MD

Role: STUDY_DIRECTOR

Samsung Medical Center

Choongho Shin, MD

Role: STUDY_DIRECTOR

Seoul National University Hospital

Jinsoon Hwang, MD

Role: STUDY_DIRECTOR

Aju University Hospital

Hoseong Kim, MD

Role: STUDY_DIRECTOR

Severance Children's Hospital Yonsei University

Wooyoung Jeong, MD

Role: STUDY_DIRECTOR

Pusan University Hospital

Chanjong Kim, MD

Role: STUDY_DIRECTOR

Chonnam National University Hospital

Heonsuk Han, MD

Role: STUDY_DIRECTOR

Chungbuk National University Hospital

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DA3002_ISS_III

Identifier Type: -

Identifier Source: org_study_id