Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency
NCT ID: NCT02693522
Last Updated: 2016-02-29
Study Results
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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COMPLETED
PHASE3
52 participants
INTERVENTIONAL
2003-10-31
2004-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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somatropin
Subcutaneous injection
somatropin
Subcutaneous injection
Eutropin
Subcutaneous injection
Eutropin
Subcutaneous injection
Interventions
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somatropin
Subcutaneous injection
Eutropin
Subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* Patients with maximum serum growth hormone concentration of less than 5 ng/ml
* Patients who can successfully complete this study based on appropriate medical judgment or who expect to benefit from this study
* Persons who have agreed in writing to participate in this study
Exclusion Criteria
* Hepatosis
* Renal function disorder
* Intra-cranial hypertension
* Proliferative diabetic retinopathy
* Persons who carry acromegaly activity
* Fertile women who are not pregnant or who do not take appropriate contraceptive measures and whose urine tested positive for hCG (human Chorionic Gonadotropin)
* Mental patients and/or drug addicts and alcoholics
* Patients who had participated in the other drug study within the last 30 days prior to participating in this study
* Patients considered unfit for this study by the attending physician
18 Years
ALL
No
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
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Locations
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Kyunghee University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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DW_CTP
Identifier Type: -
Identifier Source: org_study_id