Dose-ranging Study of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications of Early Decompensated Liver Cirrhosis
NCT ID: NCT01904409
Last Updated: 2019-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
420 participants
INTERVENTIONAL
2013-06-30
2015-07-31
Brief Summary
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Rifaximin, a non-systemic antibacterial agent, is currently marketed as a 550 mg tablet for the reduction in risk of recurrent overt hepatic encephalopathy, a complication of liver cirrhosis. The rifaximin SSD tablet was formulated to maximize the efficacy of rifaximin.
Subjects will receive 1 of 5 doses of rifaximin SSD tablets or placebo tablets every day for 24 weeks.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
Placebo tablets once daily.
Placebo
Rifaximin SSD 40 mg IR tablet
Rifaximin soluble solid dispersion (SSD) 40 mg immediate release (IR) tablet once daily.
Rifaximin SSD 40 mg IR tablet
Rifaximin SSD 80 mg IR tablet
Rifaximin soluble solid dispersion (SSD) 80 mg immediate release (IR) tablet once daily.
Rifaximin SSD 80 mg IR tablet
Rifaximin SSD 40 mg SER tablet
Rifaximin soluble solid dispersion (SSD) 40 mg sustained extended release (SER) tablet once daily.
Rifaximin SSD 40 mg SER tablet
Rifaximin SSD 80 mg SER tablet
Rifaximin soluble solid dispersion (SSD) 80 mg sustained extended release(SER) tablet once daily.
Rifaximin SSD 80 mg SER tablet
Rifaximin SSD 80mgIR/80mgSER tablet
Rifaximin soluble solid dispersion (SSD) 80 mg immediate release (IR) tablet + rifaximin SSD 80 mg sustained extended release (SER) tablet once daily.
Rifaximin SSD 80mgIR/80mgSER tablet
Interventions
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Placebo
Rifaximin SSD 40 mg IR tablet
Rifaximin SSD 80 mg IR tablet
Rifaximin SSD 40 mg SER tablet
Rifaximin SSD 80 mg SER tablet
Rifaximin SSD 80mgIR/80mgSER tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Model End Stage Liver Disease (MELD) score of at least 12, MELD Na of at least 12, or Child-Pugh B (score of 7 - 9).
* If applicable, has a close family or other personal contacts who can provide continuing oversight to the patient and will be available to the patient during the conduct of the trial.
* If female of childbearing potential, have a negative serum pregnancy test at study start and agree to use an acceptable method of contraception during the study.
Exclusion Criteria
* History of alcohol abuse or substance abuse within the past 3 months prior to study start.
* Documented cholestatic liver disease such as primary sclerosing cholangitis.
* Had prophylactic variceal banding within 2 weeks or is scheduled to undergo prophylactic banding during the study.
* Diagnosed with an infection for which the patient is currently taking oral or parenteral antibiotics.
* Significant hypovolemia, or any electrolyte abnormality that can affect mental function (eg, serum sodium \< 125 mEq/L, serum calcium \> 10 mg/dL).
* Severe hypokalemia, defined as serum potassium concentration \< 2.5 mEq/L.
* Anemic, defined as hemoglobin concentration ≤ 8 g/dL.
* Renal insufficiency with a creatinine of ≥ 1.5 mg/dL.
* Presence of intestinal obstruction or inflammatory bowel disease.
* Uncontrolled Type 1 or Type 2 diabetes.
* History of seizure disorders.
* Unstable cardiovascular or pulmonary disease, categorized by a worsening in the disease condition that requires a change in treatment or medical care within 30 days of study start.
* Active malignancy within the last 5 years (exceptions: basal cell carcinomas of the skin, or if female, in situ cervical carcinoma that has been surgically excised).
* Has hepatocellular carcinoma.
* Known human immunodeficiency virus, varicella, herpes zoster, or other severe viral infection within 6 weeks of study start.
* Positive stool test for Yersinia enterocolitica, Campylobacter jejuni, Salmonella, Shigella, ovum and parasites, and/or Clostridium difficile (C. difficile); determined during the screening period prior to study start.
* History of tuberculosis infection and/or has received treatment for a tuberculosis infection.
* History of hypersensitivity to rifaximin, rifampin, rifamycin antimicrobial agents, or any of the components of rifaximin soluble solid dispersion.
* Used any investigational product or device, or participated in another research study within 30 days prior to study start.
18 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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James Joffrion
Role: STUDY_DIRECTOR
Bausch Health Americas, Inc.
Locations
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Salix Investigative Site
Birmingham, Alabama, United States
Salix Investigative Site
Dothan, Alabama, United States
Salix Investigative Site
Mobile, Alabama, United States
Salix Investigative Site
Tucson, Arizona, United States
Salix Investigational Site
Artesia, California, United States
Salix Investigational Site
Bakersfield, California, United States
Salix Investigational Site
Chula Vista, California, United States
Salix Investigational Site
Coronado, California, United States
Salix Investigational Site
Costa Mesa, California, United States
Salix Investigative Site
Fresno, California, United States
Salix Investigational Site
La Jolla, California, United States
Salix Investigative Site
Los Angeles, California, United States
Salix Investigational Site
Monterey, California, United States
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Riverside, California, United States
Salix Investigational Site
San Diego, California, United States
Salix Investigational Site
Ventura, California, United States
Salix Investigational Site
Englewood, Colorado, United States
Salix Investigational Site
Littleton, Colorado, United States
Salix Investigational Site
Bristol, Connecticut, United States
Salix Investigational Site
New Haven, Connecticut, United States
Salix Investigational Site
Waterbury, Connecticut, United States
Salix Investigational Site
Coral Gables, Florida, United States
Salix Investigational Site
Gainesville, Florida, United States
Salix Investigative Site
Hialeah, Florida, United States
Salix Investigational Site
Hialeah, Florida, United States
Salix Investigational Site
Hollywood, Florida, United States
Salix Investigative Site
Inverness, Florida, United States
Salix Investigational Site
Lake Worth, Florida, United States
Salix Investigative Site
Largo, Florida, United States
Salix Investigative Site
Maitland, Florida, United States
Salix Investigational Site
Miami, Florida, United States
Salix Investigational Site
Miami, Florida, United States
Salix Investigational Site
Miami, Florida, United States
Salix Investigational Site
Miami Springs, Florida, United States
Salix Investigational Site
New Port Richey, Florida, United States
Salix Investigative Site
Orlando, Florida, United States
Salix Investigational Site
Pembroke Pines, Florida, United States
Salix Investigational Site
Port Orange, Florida, United States
Salix Investigational Site
Saint Cloud, Florida, United States
Salix Investigational Site
Tamarac, Florida, United States
Salix Investigational Site
Atlanta, Georgia, United States
Salix Investigative Site
Atlanta, Georgia, United States
Salix Investigative Site
Decatur, Georgia, United States
Salix Investigational Site
Macon, Georgia, United States
Salix Investigative Site
Chicago, Illinois, United States
Salix Investigative Site
Maywood, Illinois, United States
Salix Investigational Site
Evansville, Indiana, United States
Salix Investigational Site
Indianapolis, Indiana, United States
Salix Investigative Site
Iowa City, Iowa, United States
Salix Investigational Site
Bowling Green, Kentucky, United States
Salix Investigational Site
Bastrop, Louisiana, United States
Salix Investigational Site
Monroe, Louisiana, United States
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New Orleans, Louisiana, United States
Salix Investigational Site
Shreveport, Louisiana, United States
Salix Investigational Site
Annapolis, Maryland, United States
Salix Investigational Site
Baltimore, Maryland, United States
Salix Investigational Site
Baltimore, Maryland, United States
Salix Investigational Site
Chevy Chase, Maryland, United States
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Hagerstown, Maryland, United States
Salix Investigational Site
Boston, Massachusetts, United States
Salix Investigational Site
Boston, Massachusetts, United States
Salix Investigational Site
Brockton, Massachusetts, United States
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Springfield, Massachusetts, United States
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Chesterfield, Michigan, United States
Salix Investigational Site
Wyoming, Michigan, United States
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Minneapolis, Minnesota, United States
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Tupelo, Mississippi, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Marlton, New Jersey, United States
Salix Investigational Site
New Brunswick, New Jersey, United States
Salix Investigative Site
Brooklyn, New York, United States
Salix Investigational Site
Flushing, New York, United States
Salix Investigational Site
New York, New York, United States
Salix Investigational Site
New York, New York, United States
Salix Investigational Site
Rochester, New York, United States
Salix Investigative Site
The Bronx, New York, United States
Salix Investigational Site
Asheville, North Carolina, United States
Salix Investigational Site
Chapel Hill, North Carolina, United States
Salix Investigative Site
Charlotte, North Carolina, United States
Salix Investigational Site
Charlotte, North Carolina, United States
Salix Investigational Site
Fayetteville, North Carolina, United States
Salix Investigational Site
Wilmington, North Carolina, United States
Salix Investigational Site
Winston-Salem, North Carolina, United States
Salix Investigative Site
Cincinnati, Ohio, United States
Salix Investigational Site
Cincinnati, Ohio, United States
Salix Investigational Site
Cleveland, Ohio, United States
Salix Investigative Site
Dayton, Ohio, United States
Salix Investigational Site
Mentor, Ohio, United States
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Portland, Oregon, United States
Salix Investigative Site
Bristol, Tennessee, United States
Salix Investigational Site
Chattanooga, Tennessee, United States
Salix Investigational Site
Nashville, Tennessee, United States
Salix Investigational Site
Nashville, Tennessee, United States
Salix Investigative Site
Arlington, Texas, United States
Salix Investigational Site
Austin, Texas, United States
Salix Investigational Site
Dallas, Texas, United States
Salix Investigational Site
Dallas, Texas, United States
Salix Investigative Site
Dallas, Texas, United States
Salix Investigational Site
Fort Worth, Texas, United States
Salix Investigational Site
Houston, Texas, United States
Salix Investigational Site
Houston, Texas, United States
Salix Investigational Site
Houston, Texas, United States
Salix Investigational Site
San Antonio, Texas, United States
Salix Investigational Site
San Antonio, Texas, United States
Salix Investigational Site
Bountiful, Utah, United States
Salix Investigative Site
Salt Lake City, Utah, United States
Salix Investigational Site
Charlottesville, Virginia, United States
Salix Investigative Site
Norfolk, Virginia, United States
Salix Investigative Site
Richmond, Virginia, United States
Salix Investigational Site
Richmond, Virginia, United States
Salix Investigative Site
Richland, Washington, United States
Salix Investigative Site
Seattle, Washington, United States
Salix Investigative Site
Krasnogorsk, , Russia
Salix Investigative Site
Moscow, , Russia
Salix Investigative Site
Novosibirsk, , Russia
Salix Investigative Site
Saint Petersburg, , Russia
Salix Investigative Site
Samara, , Russia
Salix Investigative Site
Smolensk, , Russia
Salix Investigative Site
Stavropol, , Russia
Countries
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References
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Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.
Bajaj JS, Hassanein TI, Pyrsopoulos NT, Sanyal AJ, Rahimi RS, Heimanson Z, Israel RJ, Rockey DC. Dosing of Rifaximin Soluble Solid Dispersion Tablets in Adults With Cirrhosis: 2 Randomized, Placebo-controlled Trials. Clin Gastroenterol Hepatol. 2023 Mar;21(3):723-731.e9. doi: 10.1016/j.cgh.2022.05.042. Epub 2022 Jun 22.
Other Identifiers
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RNLC2131
Identifier Type: -
Identifier Source: org_study_id
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