NCT00191529已完成3 期
Optimization of Growth Hormone Treatment in Short Children Born Small for Gestational Age Based on a Growth Prediction Model-The OPTIMA Trial
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The 2 different doses used are non-inferior to each other
研究概览
简要总结
Comparison of 2 different doses of human growth hormone treatment on change in height after 1 and 2 years of treatment.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born small for gestational age
- •actual body height less than or equal -3 SDS
- •chronological age greater than 3 years
排除标准
- •Growth hormone deficiency
- •any defined syndromal disease
- •Diabetes mellitus
结局指标
主要结局
The 2 different doses used are non-inferior to each other
次要结局
- Safety profiles
- Compare absolute height velocity
研究者
研究点 (2)
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