Status:
COMPLETED
Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext
Lead Sponsor:
ALK Nordic A/S, Danmark Filial
Conditions:
Handling of Auto-injectors
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief 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 charac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01887405
Start Date
January 1 2012
End Date
September 1 2012
Last Update
June 26 2013
Active Locations (1)
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1
Asthma and Allergy Clinic at St Göran's Hospital
Stockholm, Sweden, 11281