- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00748904
Rifaximin Versus Lactulose in Renal Failure
January 24, 2022 updated by: Weill Medical College of Cornell University
A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Progressive Renal Failure
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Weill Cornell Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- cirrhosis of liver of any etiology
- progressive renal failure
- stage 0-2 hepatic encephalopathy
Exclusion Criteria:
- pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
35 patients receiving rifaximin
|
400 mg orally
Other Names:
|
Experimental: B
35 patients receiving lactulose
|
20 grams titrate to 2-3 bowel movements in one day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
slower progression to severe hepatic encephalopathy, stage 3 or 4
Time Frame: during hospitalization
|
during hospitalization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Anticipated)
July 1, 2009
Study Completion (Anticipated)
July 1, 2009
Study Registration Dates
First Submitted
September 8, 2008
First Submitted That Met QC Criteria
September 8, 2008
First Posted (Estimate)
September 9, 2008
Study Record Updates
Last Update Posted (Actual)
February 8, 2022
Last Update Submitted That Met QC Criteria
January 24, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0801009635
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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