NCT02693522已完成3 期
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 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2003年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Degree of fat mass (FM) reduction
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of recombinant human growth hormone on adult growth hormone deficiency
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
somatropin
Experimental
Subcutaneous injection
干预措施: somatropin (Drug)
Eutropin
Active Comparator
Subcutaneous injection
干预措施: Eutropin (Drug)
结局指标
主要结局
Degree of fat mass (FM) reduction
时间窗: baseline and 24 weeks
statistically difference for change from baseline (kg)
次要结局
- 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)
研究者
研究点 (1)
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