Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596252
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Double-blind Randomized Non-inferiority Phase III Trial on the Efficacy and Tolerability of 2 Mg Once Daily Vs 1 Mg Twice Daily Budesonide Orodispersible Tablets for Induction of Histological Remission in Adults with Eosinophilic Esophagitis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EOS-4
Brief Summary:
The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None