Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext
NCT ID: NCT01887405
Last Updated: 2013-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
91 participants
INTERVENTIONAL
2012-01-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Adrenaline: Session 1 Jext, 2 Epipen
Subjects will be randomised 1:1 to use Jext in session 1 and EpiPen in session 2.
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
Adrenaline: Session 1 Epipen, 2 Jext
Subjects will be randomised 1:1 to use EpiPen in session 1 and Jext in session 2.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
ALL
No
Sponsors
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ALK Nordic A/S, Danmark Filial
INDUSTRY
Responsible Party
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Principal Investigators
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Victoria Strand, MD Phd
Role: PRINCIPAL_INVESTIGATOR
Asthma and Allergy Clinic at St Göran's Hospital, Stockholm, Sweden
Locations
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Asthma and Allergy Clinic at St Göran's Hospital
Stockholm, , Sweden
Countries
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Other Identifiers
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JX-A-01
Identifier Type: -
Identifier Source: org_study_id
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