Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext
Information source: ALK Nordic A/S, Danmark Filial
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Handling of Auto-injectors
Intervention: Adrenaline auto-injector (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: ALK Nordic A/S, Danmark Filial Official(s) and/or principal investigator(s):
Victoria Strand, MD Phd, Principal Investigator, Affiliation: Asthma and Allergy Clinic at St Göran's Hospital, Stockholm, Sweden
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).
Clinical Details
Official title: Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext; the HEJ-study
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Non-inferiority of Jext compared with EpiPen for the proportion of subjects with a successful self-injection.
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
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Asthma and Allergy Clinic at St Göran's Hospital, Stockholm 11281, Sweden
Additional Information
Starting date: January 2012
Last updated: June 24, 2013
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