New York, New York 10021


The purpose of this study is to evaluate patients with cirrhosis of the liver and renal failure and determine if the administration of rifaximin as compared to lactulose is associated with less frequent and/or slower progression to severe hepatic encephalopathy. If one is associated with lower blood ammonia levels. And, if one is associated with lower breath hydrogen and methane levels.


Inclusion Criteria: - cirrhosis of liver of any etiology - progressive renal failure - stage 0-2 hepatic encephalopathy Exclusion Criteria: - pregnant women

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

Rifaximin Versus Lactulose in Renal Failure

Official Title:

A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Progressive Renal Failure

Overall Status:


Study Phase:

Phase 4



Minimum Age:

18 Years

Maximum Age:

65 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Weill Medical College of Cornell University

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Primary Contact:Samuel Sigal, MD
Backup Contact:Amy Tilara, MD

Study Dates

Start Date:June 2008
Completion Date:July 2009
Completion Type:Anticipated
Primary Completion Date:July 2009
Primary Completion Type:Anticipated
Verification Date:January 2011
Last Changed Date:January 3, 2011
First Received Date:September 8, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:slower progression to severe hepatic encephalopathy, stage 3 or 4
Time Frame:during hospitalization
Safety Issues:False

Study Interventions

Intervention Type:Drug
Description:400 mg orally
Arm Name:A
Other Name:Xifaxin, Salix Pharmaceuticals
Intervention Type:Drug
Description:20 grams titrate to 2-3 bowel movements in one day
Arm Name:B

Study Arms

Study Arm Type:Experimental
Arm Name:A
Description:35 patients receiving rifaximin
Study Arm Type:Experimental
Arm Name:B
Description:35 patients receiving lactulose

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Weill Medical College of Cornell University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source:

Date Processed: January 21, 2020

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