Completed

NCT Number: NCT01887405

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

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).

Completed

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Key information

Conditions

Handling of Auto-injectors

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asthma and Allergy Clinic at St Göran's Hospital

Stockholm, 11281, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adrenaline auto-injector

Drug

Each subject will be randomly assigned to use either the Jext or EpiPen first. The alternative auto-injector will then be used by the same subject in the second study session.

Valid for both Jext and Epipen:

Active ingredients: Adrenaline tartrate Dosage form: Prefilled auto-injector for single use, delivering one intramuscular injection Dose/strength: 150 μg Excipients: Sodium chloride, sodium metabisulphite (E223), hydrochloric acid (for pH adjustment), water

Other names: Jext, Epipen

Primary outcomes

Non-inferiority of Jext compared with EpiPen for the proportion of subjects with a successful self-injection.

Time frame: 1 day
The following steps were recorded as correctly done or not by the observer in a check list approach (yes/no):
- The subject identified the safety cap.
- The subject removed the safety cap.
- The subject identified the end of the auto-injector where the needle presents itself
- The subject used sufficient force to actuate the injection.
- The subject injected the auto-injector into the anterolateral thigh at a right angle (approximately 90°) to the thigh.
- 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).

Secondary outcomes

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

Time frame: 1 day
For evaluation of the secondary endpoints, the observer assessed the following:

The time used for the actuation of the injection, i.e. the time from starting to read the instructions to having injected the adrenaline as recorded by a stop watch. This time was divided into two parts:
- The time for reading the information
- The time used to perform the injection Any hesitation from the subject to actuate the injection on a 4-step scale: None, Minor, Severe or Completely Inhibited (i.e. no injection)
At the end of the second session the subject was asked the following question: "Which auto-injector do you prefer?" The following responses were possible:

Jext / EpiPen / I don't have any preference for any of the auto-injectors. The preference is a secondary endpoint.

Other outcomes

Evaluation of instructions and AEs

Time frame: 1 day

After the injection the subject evaluated the package of instructions (leaflet as well as the information on the auto-injector) for the following (yes/no):

Were the instructions concise? Were the instructions comprehensible? Do you have any further questions concerning the instructions or do you see any lack of clarity? These have been assessed as other endpoints.

Safety assessments included recording of all AEs and serious adverse events (SAEs) were done.

Sponsors and collaborators

Lead sponsor

ALK Nordic A/S, Danmark Filial

Industry

Registry information

Official study title

Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext; the HEJ-study

Acronym: HEJ

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Jun 26, 2013
Registry last updated: Jun 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.