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
SV Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Pre-pubertal children in the age group of 4-12 years of age.
- •2. 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.
- •4. 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
- •3. Known hypersenitivity to the Investigational products
- •4.Any systemic disorder likely to affect pharmacological action of somatropin.
研究者
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