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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by University of Miami.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Salix Pharmaceuticals
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00364689
First received: August 15, 2006
Last updated: June 23, 2010
Last verified: April 2007

August 15, 2006
June 23, 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 ClinicalTrials.gov 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.

Background:

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hepatic Encephalopathy
Drug: Rifaximin alone, Rifaximin combined with Lactulose
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact: Lennox J. Jeffers, MD 305-243-5787 LJeffers@med.miami.edu
Contact: Macy Ho, CRC 305-243-4648 mho@med.miami.edu
United States
 
NCT00364689
EPROST #200060006, WIRB #20060298
Not Provided
Not Provided
University of Miami
Salix Pharmaceuticals
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