Viewing Study NCT00292344



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Study NCT ID: NCT00292344
Status: COMPLETED
Last Update Posted: 2009-04-20
First Post: 2006-02-13

Brief Title: Rifaximin Loperamide and the Combination to Treat Travelers Diarrhea
Sponsor: The University of Texas Health Science Center Houston
Organization: The University of Texas Health Science Center Houston

Study Overview

Official Title: Rifaximin in Standard Three-Day Dosing With and Without the Antimotility Drug Loperamide in the Treatment of Travelers Diarrhea
Status: COMPLETED
Status Verified Date: 2006-02
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: Most cases of travelers diarrhea are caused by bacterial pathogens which respond slowly to antibiotic treatmentThe study was designed to determine the value of rapidly acting loperamide imodium combined with curative dose of the poorly absorbed rifaximin in travelers diarreha treatment
Detailed Description: During short-term study adult US students in Mexico n 310 with acute diarrhea 3 unformed stools with enteric symptoms were enrolled in a double-blind randomized trial wherein they were given rifaximin 200 mg three times a day for 3 days R n 102 loperamide 4 mg initially followed by 2 mg after each unformed stool not to exceed 8 mgday for 2 days L n 104 or both drugs in the same dosage schedule LR n 104 The major outcome parameter was time from initiation of therapy until passage of the last unformed stool before becoming well TLUS

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