NCT01529840已完成3 期
Norditropin Treatment in Subjects With Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up Visit
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
- 24
- 试验地点
- 1
- 主要终点
- Change in height SDS (Standard Deviation Score) from start of treatment to final height (referenced to normal population)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to evaluate the effect of somatropin (Norditropin®) on final height in children with Noonan syndrome having being treated for up to 10 years with somatropin (Norditropin®) for the attainment of an optimal final height in the original trial S/GHD/004/NOO.
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
- •Participation in the original S/GHD/004/NOO trial or following the protocol for S/GHD/004/NOO without being randomised in the trial
排除标准
- 未提供
研究组 & 干预措施
Low dose 33 mcg/kg/day
Experimental
干预措施: somatropin (Drug)
High dose 66 mcg/kg/day
Experimental
干预措施: somatropin (Drug)
结局指标
主要结局
Change in height SDS (Standard Deviation Score) from start of treatment to final height (referenced to normal population)
次要结局
- Number and proportion of subjects with final height SDS above -2 SDS
- Adverse events
- Change in height velocity
- Sitting height
- Change in height SDS from start of treatment to final height (referenced to Noonan population)
- Final height SDS
- Height velocity
研究者
研究点 (1)
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