NCT01110928已完成不适用
A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Patients With SGA Short Stature Without Closure of Epiphyseal Discs
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
- 227
- 试验地点
- 1
- 主要终点
- Number and type of suspected serious adverse drug reactions (SADRs) during the study period
研究概览
简要总结
This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® in the long-term treatment of patients with a SGA (small for gestational age) short stature where the growth plate in the long bones (epiphyseal disc) is not closed. An extension to the GHLIQUID-1517 trial (NCT00184717).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the GHLIQUID-1517 trial
- •Patients with SGA (small for gestational age) short stature that are still growing
排除标准
- •Known or suspected allergy to study product(s) or related products
- •Diabetes Mellitus
- •Patients with malignant tumor(s)
- •Pregnant or likely to get pregnant
研究组 & 干预措施
Norditropin®
干预措施: somatropin (Drug)
结局指标
主要结局
Number and type of suspected serious adverse drug reactions (SADRs) during the study period
时间窗: evaluated binannually for 9 years
次要结局
- Number of glucose intolerance events during the study period(evaluated biannually for 9 years)
- Adult height(Fulfilment will be evaluated once a year. Height when closure of ephiphyseal discs exists or when accomplished adult height is confirmed by physician)
研究者
研究点 (1)
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