Trial · NCT01887405
Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext
NCT01887405, Phase 4, Completed, ALK Nordic A/S, Danmark Filial
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext. Trials, record NCT01887405. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01887405
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext
- NCT number
- NCT01887405
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 91 participants, actual
- Lead sponsor
- ALK Nordic A/S, Danmark Filial
- Conditions
- Handling of Auto-injectors
- Interventions
- Adrenaline auto-injector
- First posted
- 2013-06-26
- Last updated
- 2013-06-26
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Non-inferiority of Jext compared with EpiPen for the proportion of subjects with a successful self-injection. | 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). |
| Secondary | 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 | 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 | Evaluation of instructions and AEs | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01887405
GET https://conductscience.org/api/trials/v1/NCT01887405/registered