NCT00184743已完成3 期
Investigation of the Efficacy and Safety of NN-220 for 48 Weeks in Adults With Growth Hormone Deficiency
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Percent change in truncal fat (kg)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who completed GHLiquid-
- •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.
排除标准
- •Subject with a history of acromegaly.
- •Subject with diabetes mellitus.
- •Subject suffering from malignancy.
- •Several medical conditions
结局指标
主要结局
Percent change in truncal fat (kg)
时间窗: from the baseline to the end of treatment
次要结局
- 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
研究者
研究点 (2)
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