Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328380
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2006-05-17
Brief Title:
Prevention of Travelers Diarrhea in Subjects Traveling Outside the US
Sponsor:
Bausch Health Americas Inc
Organization:
Bausch Health Americas Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study Evaluating the Safety of Rifaximin for the Prevention of Travelers Diarrhea in Subjects Traveling Outside the United States
Status:
COMPLETED
Status Verified Date:
2019-11
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:
None
Brief Summary:
The primary objective of this study is to assess the safety and tolerability of rifaximin 600 mg 3 x 200-mg tablets once daily compared with placebo when taken for 14 days by healthy subjects to prevent travelers diarrhea TD from all causes
Detailed Description:
Travelers diarrhea TD is the most common illness in travelers to the developing world occurring in 60 or more of international travelers to high-risk areas It can be quite debilitating for the usual 2 to 4 days of the illness and may lead to disruption of travel plans Findings from recent studies have indicated that the chronic post-travel illness may prove to be of greater clinical and public health significance than the acute illness Specifically persistent diarrhea has been reported in 2 to 10 of travelers developing diarrhea Moreover bacterial enterocolitis including that associated with TD leads to post-infectious irritable bowel syndrome in 4 to 31 of patients
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