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Completed Phase 4 Interventional Results available

The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy

ClinicalTrials.gov ID: NCT01842581

Public ClinicalTrials.gov record NCT01842581. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 5:45 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Randomized, Open-Label, Active-Controlled, Trial to Evaluate the Safety and Efficacy of Rifaximin 550 mg With and Without Lactulose in Subjects With a History of Recurrent Overt Hepatic Encephalopathy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.

Study identification

NCT ID
NCT01842581
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Bausch Health Americas, Inc.
Industry
Enrollment
222 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 8, 2013 (Actual)
Primary completion
Dec 17, 2014 (Actual)
Completion
Dec 17, 2014 (Actual)
Last update posted
Sep 9, 2019

2013 – 2014

United States locations

U.S. sites
43
U.S. states
22
U.S. cities
38
Facility City State ZIP Site status
Banner Research Phoenix Arizona 85016 —
Southern California Liver Centers Coronado California 92118 —
UCSF/Fresno - CRMC Fresno California 93721 —
UCSD Clinical & Translational Research Institute La Jolla California 92037 —
Salix Site Long Beach California 90822 —
Inland Empire Liver Foundation Rialto California 92377 —
Salix Site Riverside California 92501 —
Salix Site San Diego California 92103 —
Salix Site San Francisco California 94115 —
University of Colorado Denver Aurora Colorado 80045 —
South Denver GI Englewood Colorado 80113 —
University of Florida Hepatology Gainesville Florida 32610-0277 —
Tampa General Medical Group Tampa Florida 33605 —
Gastroenterology Associates Macon Georgia 31201 —
Salix Site Chicago Illinois 60611 —
Indiana University Indianapolis Indiana 46202 —
Central Iowa Hospital Corp Des Moines Iowa 50309-1453 —
Salix Site Jefferson Louisiana 70124 —
Delta Research Partners, LLC Monroe Louisiana 71201 —
The Center for Liver and Biliary Disease Baltimore Maryland 21202-2165 —
Brigham and Women's Hospital Division of Gastroenterology & Hepatology Boston Massachusetts 02115 —
Mayo Clinic Rochester Minnesota 55905 —
Kansas City Research Institute Kansas City Missouri 64131 —
St. Louis University St Louis Missouri 63104 —
Univ. of Nebraska Medical Center Omaha Nebraska 68198-3285 —
Concorde Medical Group PLLC New York New York 10016 —
New York University Medical Center New York New York 10016 —
Salix Site New York New York 10016 —
Columbia University Medical Ctr. Center for Liver Disease & Transplantation New York New York 10032 —
University of Rochester Strong Memorial Hospital Rochester New York 14642 —
Asheville Gastroenterology Associates, PA Asheville North Carolina 28801 —
UNC School of Medicine/Division of Gastroenterology and Hepatology Chapel Hill North Carolina 27599-7584 —
Carolina Medical Center Charlotte North Carolina 28204 —
Integris Nazh Zuhdi Transplant Institute Oklahoma City Oklahoma 73112 —
Albert Einstien Medical Center Philadelphia Pennsylvania 19141 —
Research Specialists of Texas Houston Texas 77030 —
Amcare Research Inc Houston Texas 77090 —
Salix Site Odessa Texas 79761 —
Alamo Medical Research San Antonio Texas 78215 —
Methodist Hospital San Antonio Texas 78229 —
University of Utah Hospital Salt Lake City Utah 84132 —
VCU/MCV Health Systems Richmond Virginia 23298 —
University of Wisconsin Hospital & Clinics Madison Wisconsin 53792 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01842581, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 9, 2019 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01842581 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →