NCT02693522
Completed
Phase 3
Phase III of the Comparative Study on the Efficacy and Safety of Recombinant Somatropin Administered to Patients With Adult Growth Hormone Deficiency
Daewoong Pharmaceutical Co. LTD.1 site in 1 country52 target enrollmentOctober 2003
Overview
- Phase
- Phase 3
- Intervention
- somatropin
- Conditions
- Growth Hormone Deficiency
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Degree of fat mass (FM) reduction
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of recombinant human growth hormone on adult growth hormone deficiency
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged 18 and up
- •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
- •Persons who are currently under treatment after being diagnosed with a malignant tumor
- •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
Arms & Interventions
somatropin
Subcutaneous injection
Intervention: somatropin
Eutropin
Subcutaneous injection
Intervention: Eutropin
Outcomes
Primary Outcomes
Degree of fat mass (FM) reduction
Time Frame: baseline and 24 weeks
statistically difference for change from baseline (kg)
Secondary Outcomes
- Degree of variation in Lean Body Mass(baseline and 24 weeks)
- Degree of variation in Waist to Hip Ratio(baseline and 24 weeks)
- Degree of variation in IGF-1(baseline and 24 weeks)
Study Sites (1)
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