New York, New York 10021


Purpose:

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.


Criteria:

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:

0801009635


NCT ID:

NCT00748904


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:

Recruiting


Study Phase:

Phase 4


Genders:

Both


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:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

70


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Samuel Sigal, MD
212-746-4129
shs2015@nyp.org
Backup Contact:Amy Tilara, MD
646-713-7284
amy.tilara@gmail.com

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
Name:Rifaximin
Description:400 mg orally
Arm Name:A
Other Name:Xifaxin, Salix Pharmaceuticals
Intervention Type:Drug
Name:Lactulose
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: ClinicalTrials.gov

Date Processed: January 21, 2020

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