Completed
Phase III Clinical Trial for Assessment of Efficacy and Safety of DA-3002 (Recombinant Human Growth Hormone) in Patients With Turner's Syndrome
What is being tested
DA-3002
+ Genotropin®
Drug
Who is being recruted
Congenital Abnormalities+21
+ Urogenital Diseases
+ Bone Diseases
From 2 to 12 Years
+8 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: February 2013
Summary
Principal SponsorDong-A ST Co., Ltd.
Last updated: July 26, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2013
Actual date on which the first participant was enrolled.A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.
Principal SponsorDong-A ST Co., Ltd.
Last updated: July 26, 2018
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
58 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 2 to 12 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Congenital AbnormalitiesUrogenital DiseasesBone DiseasesBone Diseases, DevelopmentalCardiovascular DiseasesEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersGonadal DysgenesisHeart Defects, CongenitalHeart DiseasesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisorders of Sex DevelopmentUrogenital AbnormalitiesCardiovascular AbnormalitiesChromosome DisordersSex Chromosome DisordersGenetic Diseases, InbornFemale Urogenital DiseasesMale Urogenital DiseasesSex Chromosome Disorders of Sex DevelopmentDwarfismTurner Syndrome
Criteria
5 inclusion criteria required to participate
Before the adolescence, Tuner stage I (breast)
Diagnosed with Turner's Syndrome through chromosome analysis
Normal thyroid function
The chronological age: 2 <= AGE <= 12
Show More Criteria
3 exclusion criteria prevent from participating
Growth hormone was administered for 12 months or longer in the past
Malignancy, CNS Trauma, Psychiatric Disorder
Treated with estrogen or adrenal androgens for 12 months or longer in the past
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Experimental0.14 IU (0.045-0.050mg)/kg/day of DA-3002 is injected for 52 weeks by changing injecting areas
Group II
Active Comparator0.14 IU (0.045-0.050mg)/kg/day of Genotropin is injected for 52 weeks by changing injecting areas
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center