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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

Page last updated: August 20, 2015

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