Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency
Phase III of the Comparative Study on the Efficacy and Safety of Recombinant Somatropin Administered to Patients With Adult Growth Hormone Deficiency
1 other identifier
interventional
52
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of recombinant human growth hormone on adult growth hormone deficiency
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2003
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 19, 2016
CompletedFirst Posted
Study publicly available on registry
February 26, 2016
CompletedFebruary 29, 2016
February 1, 2016
1.2 years
January 19, 2016
February 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Degree of fat mass (FM) reduction
statistically difference for change from baseline (kg)
baseline and 24 weeks
Secondary Outcomes (3)
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 Arms (2)
somatropin
EXPERIMENTALSubcutaneous injection
Eutropin
ACTIVE COMPARATORSubcutaneous injection
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyunghee University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2016
First Posted
February 26, 2016
Study Start
October 1, 2003
Primary Completion
December 1, 2004
Study Completion
December 1, 2004
Last Updated
February 29, 2016
Record last verified: 2016-02