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

Information source: Dong-A ST Co., Ltd.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Turner's Syndrome

Intervention: DA-3002 (Drug); Genotropin® (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Dong-A ST Co., Ltd.

Official(s) and/or principal investigator(s):
Han Wook Yoo, M.D., Ph.D., Principal Investigator, Affiliation: Asan Medical Center
Byung Kyu Suh, M.D., Ph.D., Principal Investigator, Affiliation: Seoul St. Mary's Hospital, The Catholic University of Korea
Cheol Woo Ko, M.D., Ph.D., Principal Investigator, Affiliation: Kyungpook National University
Kee Hyoung Lee, M.D., Ph.D., Principal Investigator, Affiliation: Korea University Anam Hospital
Dong Kyu Jin, M.D.,Ph.D., Principal Investigator, Affiliation: Seoul Medical Center
Choong Ho Shin, M.D., Ph.D., Principal Investigator, Affiliation: Seoul National University Hospital
Jin Soon Hwang, M.D., Ph.D., Principal Investigator, Affiliation: Aju University Hospital
Ho Seong Kim, M.D., Ph.D., Principal Investigator, Affiliation: Severance Children's Hospital Yonsei University
Woo Young Jeong, M.D., Ph.D., Principal Investigator, Affiliation: Pusan University Hospital
Chang Jong Kim, M.D., Ph.D., Principal Investigator, Affiliation: Chonnam National University Hospital
Heon Suk Han, M.D., Ph.D., Principal Investigator, Affiliation: Chungbuk National University Hospital

Overall contact:
Dong Kyu Jin, M.D., Ph.D., Phone: 82-2-1599-3114

Summary

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

Clinical Details

Official title: Phase III Clinical Trial for Assessment of Efficacy and Safety of DA-3002 (Recombinant Human Growth Hormone) in Patients With Turner's Syndrome

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: A comparison of annualized height velocity between the DA-3002 treated group and the Genotropin® treated group after 52 weeks

Secondary outcome: A difference of Height Standard Deviation Score between the DA treated group and the Genotropin® treated group after 52 weeks

Eligibility

Minimum age: 2 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Dong Kyu Jin, M.D., Ph.D., Phone: 82-2-1599-3114

Samsung Medical Center, Seoul, Korea, Republic of; Recruiting
Jin Dong Kyu, M.D., Ph.D., Phone: 82-2-1599-3114
Additional Information

Starting date: February 2013
Last updated: August 12, 2013

Page last updated: August 20, 2015

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