Rifaximin Versus Lactulose in Renal Failure

NCT ID: NCT00748904

Last Updated: 2022-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Cirrhosis Renal Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

35 patients receiving rifaximin

Group Type EXPERIMENTAL

Rifaximin

Intervention Type DRUG

400 mg orally

B

35 patients receiving lactulose

Group Type EXPERIMENTAL

Lactulose

Intervention Type DRUG

20 grams titrate to 2-3 bowel movements in one day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rifaximin

400 mg orally

Intervention Type DRUG

Lactulose

20 grams titrate to 2-3 bowel movements in one day

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Xifaxin, Salix Pharmaceuticals

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Weill Cornell Medical Center

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0801009635

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Oral Gut Liver Axis in Cirrhosis
NCT03030820 COMPLETED NA
FMT in Cirrhosis and Hepatic Encephalopathy
NCT03796598 COMPLETED PHASE1/PHASE2