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Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext

NCT01887405 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2013-06-26

No results posted yet for this study

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).

Conditions

  • Handling of Auto-injectors

Interventions

DRUG

Adrenaline auto-injector

Each subject will be randomly assigned to use either the Jext or EpiPen first. The alternative auto-injector will then be used by the same subject in the second study session. Valid for both Jext and Epipen: Active ingredients: Adrenaline tartrate Dosage form: Prefilled auto-injector for single use, delivering one intramuscular injection Dose/strength: 150 μg Excipients: Sodium chloride, sodium metabisulphite (E223), hydrochloric acid (for pH adjustment), water

Sponsors & Collaborators

  • ALK Nordic A/S, Danmark Filial

    lead INDUSTRY

Principal Investigators

  • Victoria Strand, MD Phd · Asthma and Allergy Clinic at St Göran's Hospital, Stockholm, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01887405 on ClinicalTrials.gov