CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 237 enrolled
Drug / intervention
Rifaximin (Xifaxan) +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Age 18 years or older
  • ✓Acute diarrhea with at least one sign of enteric infection (fever, nausea/loss of appetite, vomiting, severe abdominal pain/discomfort)
  • ✓Positive Clostridium difficile stool toxin assay at screening
Key exclusion· 3
  • ✕Previous episode of clinically diagnosed C. difficile within the past 6 months
  • ✕Chronic diseases associated with diarrhea (e.g., inflammatory bowel disease or diarrhea-predominant irritable bowel syndrome)
  • ✕Prior therapy with any agent for treatment of C. difficile prior to randomization

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00269399
NCT00269399Phase 3Completed
CompareCT.gov

A Double-Blind, Randomized, Controlled Trial of Rifaximin Compared to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

Bausch Health Americas, Inc.·interventional·Posted Dec 23, 2005·Updated Oct 14, 2019

In Brief

A Phase 3 clinical trial evaluating Rifaximin (Xifaxan) and Vancomycin for Clostridium Infections and Diarrhea. Completed, enrolled 237 participants across 63 sites.

Detailed Summary

The purpose of this study is to assess the treatment and safety of a 10-day course of rifaximin (Xifaxan) as compared to vancomycin for treatment of Clostridium difficile-associated diarrhea (CDAD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Infections, Diarrhea
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 23, 2005
Enrollment StartDec 1, 2005
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.5 years ago

Interventions

Rifaximin (Xifaxan)drug

Vancomycindrug