Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext; the HEJ-study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Non-inferiority of Jext compared with EpiPen for the proportion of subjects with a successful self-injection.
研究概览
简要总结
The purpose of the study is to demonstrate non-inferiority of Jext compared with EpiPen for the proportion of subjects with a successful self-injection. And to evaluate and compare the handling characteristics of two auto-injectors (Jext and EpiPen).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained before entering the study 1
- •Prescription of EpiPen or AnaPen for at least 2 months
- •Age ≥16 years
- •Body weight >50 kg
- •Subject willing and able to comply with study protocol
排除标准
- •Any of the following concomitant diseases: cardiovascular disease, e.g. arrhythmias or signs of coronary atherosclerosis, heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus, cancer, hyperthyroidism, severe renal impairment
- •Known blood-born infection, e.g. hepatitis and/or HIV
- •Concomitant treatment with medication which may potentiate the effect of adrenaline, e.g. catechol-O-methyl transferase (COMT) inhibitors, monoamine oxidase (MAO) inhibitors and tricyclic antidepressants
- •Pregnancy
- •Being immediate family of the investigator or study staff, defined as the investigator's/staff's spouse, parent, child, grandparent or grandchild
研究组 & 干预措施
Adrenaline: Session 1 Jext, 2 Epipen
Subjects will be randomised 1:1 to use Jext in session 1 and EpiPen in session 2.
干预措施: Adrenaline auto-injector (Drug)
Adrenaline: Session 1 Epipen, 2 Jext
Subjects will be randomised 1:1 to use EpiPen in session 1 and Jext in session 2.
干预措施: Adrenaline auto-injector (Drug)
结局指标
主要结局
Non-inferiority of Jext compared with EpiPen for the proportion of subjects with a successful self-injection.
时间窗: 1 day
The following steps were recorded as correctly done or not by the observer in a check list approach (yes/no): 1. The subject identified the safety cap. 2. The subject removed the safety cap. 3. The subject identified the end of the auto-injector where the needle presents itself 4. The subject used sufficient force to actuate the injection. 5. The subject injected the auto-injector into the anterolateral thigh at a right angle (approximately 90°) to the thigh. 6. The time spent for the injection of adrenaline was more than 10 seconds, i.e. with the needle in situ. If all 6 steps were performed correctly, the injection was considered as successful. These data form the basis for evaluation of the binary primary endpoint (successful injection or not).
次要结局
- To evaluate and compare the handling characteristics of two auto-injectors (Jext and EpiPen) regarding subject preference for one of the two auto-injectors over the other, the time to perform the injection and any hesitance to perform the injection(1 day)