Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector When Administering Saizen® Growth Hormone to Children With Growth Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 834
- 主要终点
- To assess children's compliance with the Saizen®, growth hormone treatment, following introduction of the new easypodTM self-injector, while comparing newly treated and previously treated children.
研究概览
简要总结
This is an international, multicenter study involving children treated with Saizen®, a growth hormone, who will be trained to use easypod, a new electronic injector and will complete a questionnaire after 12 week of use.
Both children naïve to growth hormone and dissatisfied with their current injection device will be recruited.
详细描述
An international, multicenter cross-sectional study (Observatoire des pratiques médicales®) involving a cohort of children treated with Saizen®, a growth hormone.
The study does not require any changes to the usual medical management of these patients and should not be considered detrimental to their physical or psychological integrity. No specific procedures or examinations will be requested, nor does the protocol require any particular treatment or follow-up visits.
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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Already treated patients who are dissatisfied with their current self-injection device, or naïve pediatric patients, in cases for which this indication is validated (growth hormone deficiency, Turner's syndrome, chronic renal failure, small-for-gestational age [SGA] patients, based on RCP)
排除标准
- •Cases in which Saizen® is contra-indicated (based on local RCP)
- •Children returning for consultation, who have not brought back their Easypod™ electronic self-injector.
- •Children who are participating in a therapeutic trial, or who have done so in the 3-month period preceding their recruitment into this observational study
结局指标
主要结局
To assess children's compliance with the Saizen®, growth hormone treatment, following introduction of the new easypodTM self-injector, while comparing newly treated and previously treated children.
时间窗: week 12
次要结局
- To assess the acceptability of the new Easypod™ electronic injector for children following a growth hormone treatment regimen.(week 12)