临床试验/NCT01327924

NCT01327924已完成不适用

Ease of Use and Tolerability of Norditropin NordiFlex® in Growth Hormone naïve Children: Impact on Daily Life

Novo Nordisk A/S0 个研究点目标入组 77 人开始时间: 2011年4月最近更新: 2014年6月24日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 77
主要终点: Usability of growth hormone injection device assessed by a quantitative scale

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study is conducted in Europe. The purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.

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: — 至 16 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Growth hormone (GH) treatment naïve subjects for whom it has been decided to initiate GH treatment prior to enrollment into the study
•Subjects who receive Norditropin NordiFlex® according to the SPC

排除标准

•Known or suspected allergy to study product(s) or related products
•Child and/or parent unable to give consent or fill out the questionnaires
•The receipt of any investigational medicinal product within 3 months prior to this study
•Suffer from a life-threatening disease

研究组 & 干预措施

Norditropin NordiFlex® users

干预措施: Norditropin NordiFlex® (Drug)

结局指标

主要结局

Usability of growth hormone injection device assessed by a quantitative scale

时间窗: after 3 months of growth hormone treatment

次要结局

Number of adverse events(from 0 - 3 months of growth hormone treatment)
Number of technical complaints(from 0 to 3 months of growth hormone treatment)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

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