AnaphylaxisPhase 4NCT01217138

Make up for the Epinephrine Autoinjector

A Phase 4 study testing Epinephrine autoinjector in people with Anaphylaxis, run by Gazi University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Part of the problems related with proper use of epinephrine autoinjector may be related with the design of the autoinjector itself.The aim of the study is to investigate whether minor modifications in the design of currently available epinephrine autoinjector ease its use and abrogate common use errors. Read more about this study

Who is it for?: Ages 21 to 26 yearsHealthy volunteers can take part
Conditions the study is for: Anaphylaxis
What is being tested?: Epinephrine autoinjector
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 164 participants
Where: No sites listed yet
Study dates: Jun 2009to May 2010
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 21 to 26 years
All sexes
Healthy volunteers accepted
Adult

Inclusion Criteria:We invited all interns in our faculty to inform about the study and included the ones who gave informed consent -

Exclusion Criteria:Interns who previously worked in allergy department were excluded.

About this study

Official title: Make up for the Epinephrine Autoinjector: Effect on Its Use by Untrained Users

Read the detailed description

All interns except the ones who previously worked in allergy department in a medical school were invited to the study. Two identical epinephrine autoinjector trainers (Epipen trainer®) were used, one of which was modified by changing gray safety cap to red and placing a yellow arrow pointing to the black injection tip. Written and visual instruction sheet for each trainer was provided. Participants were asked to demonstrate the use of Epipen trainer either with the original or the modified one. They were scored and timed for demonstration. Primary study parameter was the rate of participants correctly demonstrating the use of epinephrine autoinjector. Secondary study parameters were the mean total score, mean time required to administer autoinjector and unintentional self injection of autoinjector into thumb.

Conditions: Anaphylaxis
Being tested: Epinephrine autoinjector
Keywords: Anaphylaxis, autoinjector, design, epinephrine
Medical subject headings: Anaphylaxis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Epinephrine autoinjectorDevice
Also called Epipen trainer®, Meridian Medical Technologies, Inc. Columbia, USA
We used 2 epinephrine autoinjector trainers and wrapped them by a gray sticky paper. Then,modified one of the trainers by changing gray safety cap to red with an atomizer paint and placing a yellow arrow pointing to the black injection tip.We provided three-step written and visual instruction sheet to use epinephrine autoinjector in Turkish same as given on the original trainer and changed that of the second trainer according to the modifications we made. Scoring system originally devised by Sicherer et al was used. Participants successively doing all steps were accepted to demonstrate autoinjector use correctly. Participants who tackled with black tip of autoinjector in order to eject needle after removing safety cap was regarded as unsuccessful since this may cause unintentional injection of epinephrine. All participants were scored and timed separately.

Study groups in NCT01217138
Study group	Role	What they receive
Original epinephrine autoinjector group	Other	Participants were given original epinephrine autoinjector trainer wrapped by a gray sticky paper. Receives: Device: Epinephrine autoinjector
Modified epinephrine autoinjector group	Active comparator	Participants were given the same epinephrine autoinjector trainer wrapped by a gray sticky paper which was modified by changing gray safety cap to red with an atomizer paint and placing a yellow arrow pointing to the black injection tip. Receives: Device: Epinephrine autoinjector

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of participants correctly demonstrating the use of epinephrine autoinjector.

Secondary outcomes (3)

Mean total score participants get during demonstration of epinephrine autoinjector use
Mean time required to administer epinephrine autoinjector
Unintentional self injection of autoinjector into thumb

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009May 2010

First posted8 Oct 2010 (estimated)
Study startJun 2009
Primary completionApr 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AnaphylaxisStudies 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 164 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01217138
Sponsor's protocol ID: 232-05/25/2009
Status last verified: Oct 2010
First submitted: 7 Oct 2010
Last updated: 8 Oct 2010
Results posted: No
Data monitoring committee: No

Publications

Bakirtas A, Arga M, Catal F, Derinoz O, Demirsoy MS, Turktas I. Make-up of the epinephrine autoinjector: the effect on its use by untrained users. Pediatr Allergy Immunol. 2011 Nov;22(7):729-33. doi: 10.1111/j.1399-3038.2011.01195.x. Epub 2011 Jul 13.
PubMed 21749463

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 2
Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients
Epinephrine, Hypersensitivity, Immediate
RecruitingObservational study
Post-market Safety Study of LUMISIGHT
Hypersensitivity Reactions
Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut
Active, not recruitingObservational study
Mechanisms of Anaphylaxis
Anaphylaxis, Allergy
RecruitingPhase 1/2
UKK-0018 as an Immunotherapeutic for Treatment of Peanut Allergies
Peanut-Induced Anaphylaxis, Peanut Allergy

All Anaphylaxis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Make up for the Epinephrine Autoinjector: Effect on Its Use by Untrained Users
ClinicalTrials.gov ID: NCT01217138
Acronym / sponsor ID: 232-05/25/2009
Conditions: Anaphylaxis
Keywords: Anaphylaxis, autoinjector, design, epinephrine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 164 participants (actual)
Lead sponsor: Gazi UniversityUniversity, hospital or other
Study start: Jun 2009
Primary completion: Apr 2010 (actual)
Study completion: May 2010 (actual)
First posted: 8 Oct 2010 (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.

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Original epinephrine autoinjector group	Other	Device: Epinephrine autoinjectorParticipants were given original epinephrine autoinjector trainer wrapped by a gray sticky paper.
Modified epinephrine autoinjector group	Active comparator	Device: Epinephrine autoinjectorParticipants were given the same epinephrine autoinjector trainer wrapped by a gray sticky paper which was modified by changing gray safety cap to red with an atomizer paint and placing a yellow arrow pointing to the black injection tip.

Who may qualify

Ages: 21 to 26 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

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
Epinephrine autoinjectorAlso: Epipen trainer®, Meridian Medical Technologies, Inc. Columbia, USAWe used 2 epinephrine autoinjector trainers and wrapped them by a gray sticky paper. Then,modified one of the trainers by changing gray safety cap to red with an atomizer paint and placing a yellow arrow pointing to the black injection tip.We provided three-step written and visual instruction sheet to use epinephrine autoinjector in Turkish same as given on the original trainer and changed that of the second trainer according to the modifications we made. Scoring system originally devised by Sicherer et al was used. Participants successively doing all steps were accepted to demonstrate autoinjector use correctly. Participants who tackled with black tip of autoinjector in order to eject needle after removing safety cap was regarded as unsuccessful since this may cause unintentional injection of epinephrine. All participants were scored and timed separately.	Device	Modified epinephrine autoinjector group, Original epinephrine autoinjector group

Primary outcome

Rate of participants correctly demonstrating the use of epinephrine autoinjector.

3 secondary outcomes

Mean total score participants get during demonstration of epinephrine autoinjector use
Mean time required to administer epinephrine autoinjector
Unintentional self injection of autoinjector into thumb

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 8 Oct 2010.
Derived from this study: PubMed 21749463Bakirtas A, Arga M, Catal F, Derinoz O, Demirsoy MS, Turktas I. Make-up of the epinephrine autoinjector: the effect on its use by untrained users. Pediatr Allergy Immunol. 2011 Nov;22(7):729-33. doi: 10.1111/j.1399-3038.2011.01195.x. Epub 2011 Jul 13.

Related trials for Anaphylaxis

Not yet recruitingPhase 2
Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients
Epinephrine, Hypersensitivity, Immediate
RecruitingObservational study
Post-market Safety Study of LUMISIGHT
Hypersensitivity Reactions
Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut
Active, not recruitingObservational study
Mechanisms of Anaphylaxis
Anaphylaxis, Allergy
RecruitingPhase 1/2
UKK-0018 as an Immunotherapeutic for Treatment of Peanut Allergies
Peanut-Induced Anaphylaxis, Peanut Allergy

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.

Arzu Bakirtas principal investigator

Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma

Mustafa Arga principal investigator

Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma

Ferhat Catal principal investigator

Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Epinephrine autoinjector in people with Anaphylaxis, run by Gazi University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 8 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

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?

Rate of participants correctly demonstrating the use of epinephrine autoinjector.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01217138, which also lists 1 linked publication.

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 8 Oct 2010.