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NCT00269399 · ClinicalTrials.gov registry record · Phase 3

A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

A Phase 3 study, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 3
Development phase
237
Enrollment target

NCT00269399: Completed Phase 3 study, sponsored by Bausch Health Americas.

NCT00269399 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 237 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00269399, a Phase 3 study, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 3
Development phase
237 participants
Enrollment target

Study 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).

Primary Outcome

Resolution or improvement of baseline signs and symptoms was assessed as * Absence of severe abdominal pain for 2 consecutive days at the test of cure (TOC) Visit (Day 14 +/-1); * Absence of fever (\< 38°C/100.4°F) for 2 consecutive days at the TOC Visit; and * 3 unformed (loose or watery) stools per day for at least 48 hours that was sustained through the TOC Visit.

Interventions

  • DRUG Vancomycin
  • DRUG Rifaximin (Xifaxan)

Trial Details

FieldValue
Enrollment Target 237 participants
Start Date 2005-12
Est. Completion 2008-12
Phase Phase 3
Bausch Health Americas

168 total trials

What the finished NCT00269399 record still lists

NCT00269399 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).

The record links to 0 conditions, and to 2 interventions - of which Vancomycin is the first listed.

NCT00269399 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00269399 about?

NCT00269399 is a clinical study titled "A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)". 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).

What is the current status of trial NCT00269399?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 237 participants. The study started on 2005-12. Estimated completion is 2008-12.

What interventions are being tested in trial NCT00269399?

The interventions under investigation include: Vancomycin (DRUG), Rifaximin (Xifaxan) (DRUG).

Who is sponsoring clinical trial NCT00269399?

This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00269399's enrollment target sits among peer trials

237 1293rd of 2000 higher than 707 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00269399, the US trial registry maintained by the National Library of Medicine. NCT00269399 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.