NCT01518036已完成3 期
The Use of Norditropin® in Turner's Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Final height in cm
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to study the dose-response relationship and effect of somatropin (Norditropin®) on final height in girls with Turner Syndrome.
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
- 2 Years 至 11 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Turner Syndrome
- •Not previously treated with growth hormone or androgen
- •Well-documented height over the previous 12 months
- •Informed consent of parents (and child if appropriate)
排除标准
- •Growth hormone (GH) deficiency based on a GH stimulation test
研究组 & 干预措施
High dose
Experimental
干预措施: somatropin (Drug)
Low dose
Experimental
干预措施: somatropin (Drug)
结局指标
主要结局
Final height in cm
次要结局
- Ratio between change in bone age and change in chronological age
- Age at onset of puberty
- Adverse events
研究者
研究点 (1)
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