Overview
Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext
Status:
Completed
Completed
Trial end date:
2012-09-01
2012-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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).Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
ALK Nordic A/S, Danmark FilialTreatments:
Epinephrine
Epinephryl borate
Racepinephrine
Criteria
Inclusion Criteria:- 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
Exclusion Criteria:
- 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