RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial
Recruitment status was Recruiting
|First Received Date ICMJE||August 15, 2006|
|Last Updated Date||June 23, 2010|
|Start Date ICMJE||August 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00364689 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial|
|Official Title ICMJE||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:
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Condition ICMJE||Hepatic Encephalopathy|
|Intervention ICMJE||Drug: Rifaximin alone, Rifaximin combined with Lactulose|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||75|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00364689|
|Other Study ID Numbers ICMJE||EPROST #200060006, WIRB #20060298|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Miami|
|Collaborators ICMJE||Valeant Pharmaceuticals International, Inc.|
|Information Provided By||University of Miami|
|Verification Date||April 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP