Ignite Creation Date:
2024-05-05 @ 11:59 PM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01463943
Status:
WITHDRAWN
Last Update Posted:
2015-07-27
First Post:
2011-10-27
Brief Title:
Non-Inferiority Trial Comparing Eurofarmas Experimental Product Saccharomyces Boulardii Versus Floratil in the Prevention of Antibiotic-Associated Diarrhea
Sponsor:
Eurofarma Laboratorios SA
Organization:
Eurofarma Laboratorios SA
Study Overview
Official Title:
An Open-Label Non-Inferiority Phase III Trial Comparing Eurofarmas Experimental Product Saccharomyces Boulardii Versus Floratil S Boulardii - Merck in the Prevention of Antibiotic-Associated Diarrhea
Status:
WITHDRAWN
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change company strategy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACROSS
Brief Summary:
The studys objective is to evaluate the efficacy and safety of two formulations for the prophylactic treatment of diarrhea in subjects using antibiotics
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