RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial

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. Identifier: NCT00364689
Recruitment Status : Unknown
Verified April 2007 by University of Miami.
Recruitment status was:  Recruiting
First Posted : August 16, 2006
Last Update Posted : June 24, 2010
Valeant Pharmaceuticals International, Inc.
Information provided by:
University of Miami

August 15, 2006
August 16, 2006
June 24, 2010
August 2006
Not Provided
  • Number of hospitalizations for HE
  • Changes in psychometric testing during study period
Same as current
Complete list of historical versions of study NCT00364689 on Archive Site
  • Number of hospitalization days for all causes
  • Death or survival to liver transplantation
  • Rate of adverse events with rifaximin treatment
Same as current
Not Provided
Not Provided
RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial
RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial

The purpose of this study is to compare the effectiveness of three different treatments for hepatic encephalopathy. These treatments are:

  • Group 1 - lactulose given with a rifaximin placebo (sugar pill)
  • Group 2 - lactulose given with rifaximin
  • Group 3 - rifaximin given alone

The goals of this study are to determine which treatment is most effective at (1) reducing admissions to hospital for hepatic encephalopathy and (2) improving mental function, during the study period.


Hepatic encephalopathy (HE) is a reversible process resulting from advanced liver disease. It can range in severity from disturbed sleep patterns to profound coma and can be triggered by a number of common factors, including intestinal bleeding, infection, constipation, and dietary changes.

This study will compare two different medications, used alone or in combination, to prevent relapses of HE. Lactulose is a laxative (causes increased bowel movements) which has been widely used in the treatment of HE. However, it is not clear how effective it is for this purpose and is not always well tolerated. Rifaximin is an oral antibiotic which has been studied in the treatment of HE, including longer treatment courses but its role in the prevention of HE relapses is not clear. No studies to date have compared the use of lactulose to combination treatment with lactulose and rifaximin in the prevention of recurrent episodes of HE.

Study Overview:

This study is a single-center, randomized, controlled trial evaluating the efficacy and safety of rifaximin, given alone or in combination with lactulose, as compared to lactulose given alone, in subjects in remission from prior acute episodes of HE. This study seeks specifically to examine the role of combination treatment with rifaximin and lactulose, as compared to either treatment alone, in maintaining remission of HE.

Our study hypothesis is that rifaximin, given alone or in combination with lactulose, will reduce the number of hospital admissions for acute HE, and will improve overall mental function during the treatment period, relative to standard lactulose therapy.

This is a double-blinded study (for rifaximin only), which means that neither you nor your study doctor will know whether you are being treated with rifaximin or a placebo pill. You will, however, know whether you are receiving lactulose.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Hepatic Encephalopathy
Drug: Rifaximin alone, Rifaximin combined with Lactulose
Not Provided
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
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Inclusion Criteria:

  • Cirrhosis of any cause
  • History of previous admission for acute HE within 1 year of screening

Exclusion Criteria:

  • History of allergy to lactulose or rifaximin.
  • Ongoing alcohol or drug dependence
  • Required use of sedatives or narcotics
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
EPROST #200060006
WIRB #20060298
Not Provided
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University of Miami
Valeant Pharmaceuticals International, Inc.
Principal Investigator: Lennox J. Jeffers, MD University of Miami
Principal Investigator: Patrick J Amar, MD University of Miami
University of Miami
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP