CTRI/2013/09/003957已完成3 期
A prospective Phase III, Multicentre, Randomised, Open Label Study to Evaluate the Comparitive Safety and Efficacy of Recombinant Human Growth Hormone (rhGH) of USV with Eutropin in the Treatment of Pre-pubertal Children (4 to 12 years) with Growth Hormone Deficency
USV Ltd7 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年1月31日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- 1) Height2) Height Standard Deviation Score 3) Height Velocity 4) Height Velocity Standard Deviation Score
研究概览
简要总结
This study is a Prospective Phase III,Multicentre,randomized,Open label study to evaluate the comparative safety and efficacy of Recombinant Human Growth Hormone of USV with Eutropin in the treatment of Pre-pubertal children(4-12 years) with growth hormone deficiency.The Primary outcome measures will be Height,Height standard deviation score,height velocity and height velocity standard deviation score after 6 months.The secondary outcome will be measuring Insulin-like Growth Factor and Insulin-like Growth Factor-Binding Protein at 0,3 and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 4.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Pre-pubertal children in the age group of 4-12 years of age.
- •Children with short stature with a growth rate 5.0 cm per year.
- •3.Children with deficiency of GH testing without any organic pathology documented by dynamic GH testing by at least 2 differnent stimuli.The post stimulation level of human GH should not be / 10 ng/ml.
- •GH defiency if due to pituitary surgery not earlier than 2 years and woth a stable disease.
排除标准
- •1.Associated endocrine disorders of thyroid function, adenocortical insufficiency(serum basal cortisol<3ug/dl) unless adequately replaced with thyroxin and showing a stable thyroid function at least for 8 weeks.2.patients already receiving rhGH treatment
- •Known hypersenitivity to the Investigational products4.Any systemic disorder likely to affect pharmacological action of somatropin.
结局指标
主要结局
1) Height2) Height Standard Deviation Score 3) Height Velocity 4) Height Velocity Standard Deviation Score
时间窗: 6 months
次要结局
- 1) Insulin-like Growth Factor-1 2) Insulin-like Growth Factor-Binding Protein-3(Measured at 0,3 and 6 months.)
研究者
研究点 (7)
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