Handling of Auto-injectors Clinical Trial
— HEJOfficial title:
Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext; the HEJ-study
| Verified date | June 2013 |
| Source | ALK Nordic A/S, Danmark Filial |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Regional Ethical Review Board |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 91 |
| Est. completion date | September 2012 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Asthma and Allergy Clinic at St Göran's Hospital | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| ALK Nordic A/S, Danmark Filial |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Evaluation of instructions and AEs | 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. |
1 day | Yes |
| Primary | 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). |
1 day | Yes |
| 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 | 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. |
1 day | Yes |