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A Clinical Study to Assess the Efficacy and Safety of DA-3002

NCT ID: NCT01813630

Last Updated: 2018-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2018-05-31

Brief Summary

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A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.

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Detailed Description

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Conditions

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Turner's Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DA-3002

0.14 IU (0.045-0.050mg)/kg/day of DA-3002 is injected for 52 weeks by changing injecting areas

Group Type EXPERIMENTAL

DA-3002

Intervention Type DRUG

Genotropin®

0.14 IU (0.045-0.050mg)/kg/day of Genotropin is injected for 52 weeks by changing injecting areas

Group Type ACTIVE_COMPARATOR

Genotropin®

Intervention Type DRUG

Interventions

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DA-3002

Intervention Type DRUG

Genotropin®

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with Turner's Syndrome through chromosome analysis
* The chronological age: 2≤AGE≤12
* The yearly growth rate should be less than 6cm; the bone age should be equal or less than 12; the height ≤ 10th percentile for the heights of their agemates
* Before the adolescence, Tuner stage I (breast)
* Normal thyroid function

Exclusion Criteria

* Growth hormone was administered for 12 months or longer in the past
* Treated with estrogen or adrenal androgens for 12 months or longer in the past
* Malignancy, CNS Trauma, Psychiatric Disorder
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Han Wook Yoo, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Byung Kyu Suh, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital, The Catholic University of Korea

Cheol Woo Ko, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Kee Hyoung Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Dong Kyu Jin, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul Medical Center

Choong Ho Shin, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Jin Soon Hwang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Aju University Hospital

Ho Seong Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Severance Children's Hospital Yonsei University

Woo Young Jeong, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Pusan University Hospital

Chang Jong Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Heon Suk Han, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chungbuk National University Hospital

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim J, Kim MS, Suh BK, Ko CW, Lee KH, Yoo HW, Shin CH, Hwang JS, Kim HS, Chung WY, Kim CJ, Han HS, Jin DK. Recombinant growth hormone therapy in children with Turner Syndrome in Korea: a phase III Randomized Trial. BMC Endocr Disord. 2021 Dec 10;21(1):243. doi: 10.1186/s12902-021-00904-5.

Reference Type DERIVED
PMID: 34893062 (View on PubMed)

Other Identifiers

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DA3002_TS_III

Identifier Type: -

Identifier Source: org_study_id

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