Handling of Auto-injectorsPhase 4HEJNCT01887405
Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext
A Phase 4 study testing Adrenaline auto-injector in people with Handling of Auto-injectors, run by ALK Nordic A/S, Danmark Filial at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Handling of Auto-injectors
- What is being tested?
- Adrenaline auto-injector
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2012to Sep 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext; the HEJ-study
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).
- Conditions
- Handling of Auto-injectors
- Being tested
- Adrenaline auto-injector
- Keywords
- Adrenaline, Auto-injector, Jext, Epipen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adrenaline auto-injectorDrug
Also called Jext, Epipen
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
| Study group | Role | What they receive |
|---|---|---|
| Adrenaline: Session 1 Jext, 2 Epipen | Active comparator | Subjects will be randomised 1:1 to use Jext in session 1 and EpiPen in session 2. Receives: Drug: Adrenaline auto-injector |
| Adrenaline: Session 1 Epipen, 2 Jext | Active comparator | Subjects will be randomised 1:1 to use EpiPen in session 1 and Jext in session 2. Receives: Drug: Adrenaline auto-injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of Jext compared with EpiPen for the proportion of subjects with a successful self-injection.
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).
Measured: 1 day
Secondary outcomes (1)
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
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Handling of Auto-injectorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK Nordic A/S, Danmark Filial
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victoria Strand, MD Phd, Principal investigator, Asthma and Allergy Clinic at St Göran's Hospital, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887405
- Sponsor's protocol ID
- JX-A-01
- Acronym
- HEJ
- Status last verified
- Jun 2013
- First submitted
- 20 Jun 2013
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext; the HEJ-study
- ClinicalTrials.gov ID
- NCT01887405
- Acronym / sponsor ID
- HEJ / JX-A-01
- Conditions
- Handling of Auto-injectors
- Keywords
- Adrenaline, Auto-injector, Jext, Epipen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- ALK Nordic A/S, Danmark FilialIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adrenaline: Session 1 Jext, 2 Epipen | Active comparator | Drug: Adrenaline auto-injectorSubjects will be randomised 1:1 to use Jext in session 1 and EpiPen in session 2. |
| Adrenaline: Session 1 Epipen, 2 Jext | Active comparator | Drug: Adrenaline auto-injectorSubjects will be randomised 1:1 to use EpiPen in session 1 and Jext in session 2. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adrenaline auto-injectorAlso: Jext, EpipenEach 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 | Drug | Adrenaline: Session 1 Epipen, 2 Jext, Adrenaline: Session 1 Jext, 2 Epipen |
Primary outcome
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): 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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Strand, MD Phd principal investigator
Asthma and Allergy Clinic at St Göran's Hospital, Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adrenaline auto-injector in people with Handling of Auto-injectors, run by ALK Nordic A/S, Danmark Filial at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of Jext compared with EpiPen for the proportion of subjects with a successful self-injection. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2013.