Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
Phase 3
Completed
- Conditions
- Growth Hormone DisorderAdult Growth Hormone Deficiency
- Registration Number
- NCT00184743
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Japan. To investigate the long-term efficacy as assessed by change in fat mass and safety after 48 weeks of treatment of Growth Hormone in adults with Growth Hormone Deficiency, comparing two different treatment regiments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
Inclusion Criteria
- Subjects who completed GHLiquid-1518.
- If the subject has a history of treatment for a tumor of pituitary or peripheral site, two years or more have to be passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be excluded.
- Appropriate replacement therapy has been administered for more than 24 weeks for the treatment of other pituitary hormone deficiencies.
Exclusion Criteria
- Subject with a history of acromegaly.
- Subject with diabetes mellitus.
- Subject suffering from malignancy.
- Several medical conditions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percent change in truncal fat (kg) from the baseline to the end of treatment
- Secondary Outcome Measures
Name Time Method Change in Total body fat, Total LBM, etc. from the baseline to the end of treatment Adverse events Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride) FPG, insulin, and HbA1C IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio Clinical laboratory tests
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇯🇵Tokyo, Japan