NCT00102817已完成3 期
Somatropin (Norditropin) in Children With Growth Failure Associated With ICF Deficiency.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 28
- 主要终点
- Change in height standard deviation score
研究概览
简要总结
This trial is conducted in the United States of America (USA). This is a 12 month study to determine if Norditropin is safe and effective in children with IGF 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
- 3 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 3-15
- •Presence of growth failure indicated by height standard deviation score less than equal to -2
- •Body mass index greater than or equal to 25th percentile for height age
- •IGF concentration less than or equal to 33rd percentile
排除标准
- 未提供
结局指标
主要结局
Change in height standard deviation score
时间窗: 12 months
次要结局
- 12 months change in height standard deviation score adjusted for parent height z-score
研究者
研究点 (28)
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