NCT01516229已完成不适用
Specific Survey of Norditropin® in Achondroplasia: Survey for Long-term Application
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 395
- 试验地点
- 1
- 主要终点
- Incidence of adverse drug reactions (ADRs)
研究概览
简要总结
This study is conducted in Japan. The aim of this study is to assess the incidence rate of adverse drug reactions (ADRs) when using somatropin (Norditropin®) for treatment of for achondroplasia without epiphyseal line closure under normal clinical practice conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Achondroplasia without epiphyseal line closure
排除标准
- 未提供
研究组 & 干预措施
Somatropin
干预措施: somatropin (Drug)
结局指标
主要结局
Incidence of adverse drug reactions (ADRs)
次要结局
- Treatment evaluation using the Foundation for Growth Science's Criteria for Treatment Continuation: Definitely effective, effective, ineffective or definitely ineffective
研究者
研究点 (1)
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