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
  Purpose

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.


Condition Intervention Phase
Hepatic Encephalopathy
Drug: Rifaximin alone, Rifaximin combined with Lactulose
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Number of hospitalizations for HE
  • Changes in psychometric testing during study period

Secondary Outcome Measures:
  • Number of hospitalization days for all causes
  • Death or survival to liver transplantation
  • Rate of adverse events with rifaximin treatment

Estimated Enrollment: 75
Study Start Date: August 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364689

Contacts
Contact: Lennox J. Jeffers, MD 305-243-5787 LJeffers@med.miami.edu
Contact: Macy Ho, CRC 305-243-4648 mho@med.miami.edu

Locations
United States, Florida
Center For Liver Diseases - University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Macy Ho, CRC    305-243-4648    mho@med.miami.edu   
Principal Investigator: Lennox J. Jeffers, MD         
Principal Investigator: Patrick J Amar, MD         
Sponsors and Collaborators
University of Miami
Salix Pharmaceuticals
Investigators
Principal Investigator: Lennox J. Jeffers, MD University of Miami
Principal Investigator: Patrick J Amar, MD University of Miami
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00364689     History of Changes
Other Study ID Numbers: EPROST #200060006, WIRB #20060298
Study First Received: August 15, 2006
Last Updated: June 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami:
Encephalopathy, Hepatic
Portosystemic Encephalopathy
Encephalopathy, Hepatocerebral
Encephalopathy, Portal-Systemic
Encephalopathy, Portosystemic
Hepatic Coma
Hepatic Stupor
Hepatocerebral Encephalopathy
Portal-Systemic Encephalopathy

Additional relevant MeSH terms:
Hepatic Encephalopathy
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Poisoning
Substance-Related Disorders
Rifaximin
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014