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The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy

NCT01842581 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2019-09-09

Study results available
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Summary

The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.

Conditions

  • Hepatic Encephalopathy
  • Cirrhosis

Interventions

DRUG

Rifaximin

Rifaximin will be administered per the dose and schedule specified in the arms.

DRUG

Lactulose

Laculose will be administered per the schedule specified in the respective arm.

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Lindsey Mathew · Bausch Health Americas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-08
Primary Completion
2014-12-17
Completion
2014-12-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01842581 on ClinicalTrials.gov