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NCT00748904 Clinical Trial

Rifaximin Versus Lactulose in Renal Failure

Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00748904
Other study ID # 0801009635
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date June 2008
Est. completion date July 2009

Study information
Verified date January 2022
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - cirrhosis of liver of any etiology - progressive renal failure - stage 0-2 hepatic encephalopathy Exclusion Criteria: - pregnant women

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Rifaximin
400 mg orally
• Lactulose
20 grams titrate to 2-3 bowel movements in one day

Locations
Country Name City State
United States Weill Cornell Medical Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary slower progression to severe hepatic encephalopathy, stage 3 or 4 during hospitalization
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