Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-29 @ 11:58 PM
Study NCT ID:
NCT01444092
Status:
COMPLETED
Last Update Posted:
2022-01-06
First Post:
2011-09-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Study of Entocort for Children With Crohn's Disease
Sponsor:
Padagis LLC
Organization:
Study Overview
Official Title:
A Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive
Status:
COMPLETED
Status Verified Date:
2022-01
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:
None
Brief Summary:
A Safety Study using Entocort EC for children with mild to moderate Crohn's Disease
Detailed Description:
A Multicenter, Open label, Non-comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: