NCT00174278已完成3 期
Treatment With Recombinant Human Growth Hormone (Genotonorm®) In Children With Short Stature Secondary To A Long Term Corticoid Therapy. A Study of Efficacy and Safety.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The main efficacy variable is the height SDS (SEMPE) before and after treatment.
研究概览
简要总结
To assess the effect of long-term treatment by Genotonorm on linear growth
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the patients who have benefit during one year of a treatment by Genotonorm during the study 94-8123-014
- •All patients who have stopped during one year will be included if a signed written informed consent
排除标准
- •Endocrine disease, except well substituted hypothyroidism
- •Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)
结局指标
主要结局
The main efficacy variable is the height SDS (SEMPE) before and after treatment.
The standing height of the patients is measured during the inclusion visit and at each follow-up visit.
The height measurements are always performed at the same time of the day by
use of a wallmounted device (e.g. Harpenden Stadiometer).
Each child has to be measured three times, the mean of these measurements is recorded in the Case Report Form as the present height.
The body weight is measured by use of a balance scale.
Puberty stage is assessed (according to Tanner´s cotation) at the same visits as height is measured.
次要结局
未报告次要终点
研究者
研究点 (1)
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