Assessment of the Ease of Use of Norditropin NordiFlex® Relative to the One of the Device Previously Used by Patients or Parents
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used
研究概览
简要总结
This study is conducted in Europe. The aim of this study is to compare the easiness of use of Norditropin NordiFlex® device to the device previously used by patients or parents.
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
- •Children who can receive Norditropin® (somatropin) treatment according to the product labelling
- •Treated with growth hormone for at least one year
排除标准
- •Contraindications to Norditropin® growth hormone therapy
- •Known or suspected hypersensitivity to somatropin or related products
- •The receipt of any investigational medicinal product within 3 months prior to study start
- •Life threatening disease, for example cancer
- •Pregnancy or the intention of becoming pregnant
研究组 & 干预措施
Nordiflex Norditropin®
Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
干预措施: Norditropin NordiFlex® (Device)
结局指标
主要结局
The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used
时间窗: Week 6
Analysed for the ITT (intent-to-treat) analysis set: The relative ease of use of the trial injection device compared to the device previously used was assessed using a quantitative scale, ranging from 0 to 10 with 0 = NordiFlex® is far less simple, 5 = equivalent simplicity and 10 = NordiFlex® is far more simple. The participants had to circle the number that represented their perception of the current state.
次要结局
- Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products(Week 6)
- Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection(Week 6)
- Percentage of Participants Evaluating Simplicity of Use: Dose Modification(Week 6)
- Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness(Week 6)
- Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection(Week 6)
- Ease of Learning Assessed by the Physician or the Nurse: Ease of Training(Week 6)
- Percentage of Participants Evaluating Simplicity of Use: Injection Easiness(Week 6)
- Ease of Learning Assessed by the Physician or the Nurse: Time Learning(Week 6)
- Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment(Week 6)
- Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial(Weeks 0 - 6)
- Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness(Week 0)
- Percentage of Participants Evaluating Simplicity of Use: Dose Modification(Week 0)
- Percentage of Participants Evaluating Simplicity of Use: Injection Easiness(Week 0)
- Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection(Week 0)
- Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection(Week 0)