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Rifaximin Versus Lactulose in Renal Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00748904
Recruitment Status : Unknown
Verified January 2011 by Weill Medical College of Cornell University.
Recruitment status was:  Recruiting
First Posted : September 9, 2008
Last Update Posted : January 4, 2011
Sponsor:
Information provided by:
Weill Medical College of Cornell University

Brief 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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Renal Failure Drug: Rifaximin Drug: Lactulose Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Progressive Renal Failure
Study Start Date : June 2008
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: A
35 patients receiving rifaximin
Drug: Rifaximin
400 mg orally
Other Name: Xifaxin, Salix Pharmaceuticals

Experimental: B
35 patients receiving lactulose
Drug: Lactulose
20 grams titrate to 2-3 bowel movements in one day




Primary Outcome Measures :
  1. slower progression to severe hepatic encephalopathy, stage 3 or 4 [ Time Frame: during hospitalization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cirrhosis of liver of any etiology
  • progressive renal failure
  • stage 0-2 hepatic encephalopathy

Exclusion Criteria:

  • pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748904


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

Locations
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United States, New York
Weill Cornell Medical Center Recruiting
New York, New York, United States, 10021
Contact: Samuel Sigal, MD    212-746-4129    shs2015@nyp.org   
Contact: Amy Tilara, MD    646-713-7284    amy.tilara@gmail.com   
Principal Investigator: Samuel Sigal, MD         
Sub-Investigator: Amy Tilara, MD         
Sub-Investigator: Ilan Weisberg, MD         
Sub-Investigator: Melanie Starcic, PA         
Sponsors and Collaborators
Weill Medical College of Cornell University

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Responsible Party: Samuel Sigal, Center for Liver Diseases and Transplantation
ClinicalTrials.gov Identifier: NCT00748904     History of Changes
Other Study ID Numbers: 0801009635
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: January 4, 2011
Last Verified: January 2011
Keywords provided by Weill Medical College of Cornell University:
cirrhosis of liver and progressive renal failure
Additional relevant MeSH terms:
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Liver Cirrhosis
Renal Insufficiency
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Rifaximin
Lactulose
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents