Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-11 @ 7:33 PM
Study NCT ID:
NCT01887405
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2013-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext
Sponsor:
ALK Nordic A/S, Danmark Filial
Organization:
Study Overview
Official Title:
Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext; the HEJ-study
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEJ
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 characteristics of two auto-injectors (Jext and EpiPen).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: