Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext (HEJ)

ALK-Abelló

Status and phase: Completed; Phase 4

Conditions: Handling of Auto-injectors

Treatments: Drug: Adrenaline auto-injector

Study type: Interventional

Funder types: Industry

Identifiers

NCT01887405

JX-A-01

Details and patient eligibility

About

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).

Enrollment: 91 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

Adrenaline: Session 1 Jext, 2 Epipen

Active Comparator group

Description:

Subjects will be randomised 1:1 to use Jext in session 1 and EpiPen in session 2.

Treatment:

Drug: Adrenaline auto-injector

Adrenaline: Session 1 Epipen, 2 Jext

Active Comparator group

Description:

Subjects will be randomised 1:1 to use EpiPen in session 1 and Jext in session 2.

Treatment:

Drug: Adrenaline auto-injector