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Dose-ranging Study of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications of Early Decompensated Liver Cirrhosis

Information source: Salix Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Liver Cirrhosis

Intervention: Placebo (Drug); Rifaximin SSD 40 mg IR tablet (Drug); Rifaximin SSD 80 mg IR tablet (Drug); Rifaximin SSD 40 mg SER tablet (Drug); Rifaximin SSD 80 mg SER tablet (Drug); Rifaximin SSD 80 mg IR tablet + rifaximin SSD 80 mg SER tablet (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Salix Pharmaceuticals

Official(s) and/or principal investigator(s):
James Joffrion, Study Director, Affiliation: Salix Pharmaceuticals

Summary

The primary objective of this study is to assess the efficacy of rifaximin SSD versus placebo in preventing complications of liver cirrhosis, such as all-cause mortality (death due to all causes) or hospitalization, in subjects with early decompensated liver cirrhosis. 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.

Clinical Details

Official title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications in Subjects With Early Decompensated Liver Cirrhosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Time to all-cause mortality or hospitalization that is attributable to complications of liver disease.

Secondary outcome:

Overall hospitalization rate due to each complication of liver disease or all-cause mortality over the 24-week treatment period.

Pharmacokinetics of rifaximin and its metabolite.

Incidence of treatment-emergent adverse events.

Change in clinical laboratory parameters.

Changes in electrocardiogram measurements

Changes in indices of health outcomes

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of liver cirrhosis and documented ascites.

- 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 a major psychiatric disorder including uncontrolled major depression or

controlled or uncontrolled psychoses within the past 24 months prior to study start.

- 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.

Locations and Contacts

Salix Investigative Site, Krasnogorsk, Russian Federation

Salix Investigative Site, Moscow, Russian Federation

Salix Investigative Site, Novosibirsk, Russian Federation

Salix Investigative Site, Petersburg, Russian Federation

Salix Investigative Site, Samara, Russian Federation

Salix Investigative Site, Smolensk, Russian Federation

Salix Investigative Site, St. Petersburg, Russian Federation

Salix Investigative Site, Stavropol, Russian Federation

Salix Investigative Site, Birmingham, Alabama 35294, United States

Salix Investigative Site, Dothan, Alabama 36305, United States

Salix Investigative Site, Mobile, Alabama 36617, United States

Salix Investigative Site, Tucson, Arizona 85712, United States

Salix Investigational Site, Artesia, California 90701, United States

Salix Investigational Site, Bakersfield, California 93301, United States

Salix Investigational Site, Chula Vista, California 91910, United States

Salix Investigational Site, Coronado, California 92118, United States

Salix Investigational Site, Costa Mesa, California 92626, United States

Salix Investigative Site, Fresno, California 93701, United States

Salix Investigational Site, La Jolla, California 92037, United States

Salix Investigative Site, Los Angeles, California 90033, United States

Salix Investigational Site, Monterey, California 93940, United States

Salix Investigational Site, Riverside, California 92377, United States

Salix Investigational Site, San Diego, California 92114, United States

Salix Investigational Site, Ventura, California 93003, United States

Salix Investigational Site, Englewood, Colorado 80113, United States

Salix Investigational Site, Littleton, Colorado 80120, United States

Salix Investigational Site, Bristol, Connecticut 06035, United States

Salix Investigational Site, New Haven, Connecticut 06520, United States

Salix Investigational Site, Waterbury, Connecticut 06708, United States

Salix Investigational Site, Coral Gables, Florida 33134, United States

Salix Investigational Site, Gainesville, Florida 32610, United States

Salix Investigational Site, Hialeah, Florida 33016, United States

Salix Investigative Site, Hialeah, Florida 33012, United States

Salix Investigational Site, Hollywood, Florida 33021, United States

Salix Investigative Site, Iverness, Florida 34452, United States

Salix Investigational Site, Lake Worth, Florida 33449, United States

Salix Investigative Site, Largo, Florida 33777, United States

Salix Investigative Site, Maitland, Florida 32751, United States

Salix Investigational Site, Miami Springs, Florida 33166, United States

Salix Investigational Site, Miami, Florida 33030, United States

Salix Investigational Site, Miami, Florida 33126, United States

Salix Investigational Site, Miami, Florida 33136, United States

Salix Investigational Site, New Port Richey, Florida 34653, United States

Salix Investigative Site, Orlando, Florida 32824, United States

Salix Investigational Site, Pembrook Pines, Florida 33024, United States

Salix Investigational Site, Port Orange, Florida 32127, United States

Salix Investigational Site, St. Cloud, Florida 34769, United States

Salix Investigational Site, Tamarac, Florida 33319, United States

Salix Investigational Site, Atlanta, Georgia 30309, United States

Salix Investigative Site, Atlanta, Georgia 30342, United States

Salix Investigative Site, Decatur, Georgia 30033, United States

Salix Investigational Site, Macon, Georgia 31201, United States

Salix Investigative Site, Chicago, Illinois 60612, United States

Salix Investigative Site, Maywood, Illinois 75390, United States

Salix Investigational Site, Evansville, Indiana 47714, United States

Salix Investigational Site, Indianapolis, Indiana 46202, United States

Salix Investigative Site, Iowa City, Iowa 52242, United States

Salix Investigational Site, Bowling Green, Kentucky 42101, United States

Salix Investigational Site, Bastrop, Louisiana 71220, United States

Salix Investigational Site, Monroe, Louisiana 71201, United States

Salix Investigational Site, New Orleans, Louisiana 70112, United States

Salix Investigational Site, Shreveport, Louisiana 71103, United States

Salix Investigational Site, Annapolis, Maryland 21401, United States

Salix Investigational Site, Baltimore, Maryland 21202, United States

Salix Investigational Site, Baltimore, Maryland 21228, United States

Salix Investigational Site, Chevy Chase, Maryland 20815, United States

Salix Investigational Site, Hagerstown, Maryland 21743, United States

Salix Investigational Site, Boston, Massachusetts 02114, United States

Salix Investigational Site, Boston, Massachusetts 02115, United States

Salix Investigational Site, Brockton, Massachusetts 02302, United States

Salix Investigational Site, Springfield, Massachusetts 01105, United States

Salix Investigative Site, Chesterfield, Michigan 48047, United States

Salix Investigational Site, Wyoming, Michigan 49519, United States

Salix Investigational Site, Minneapolis, Minnesota 55455, United States

Salix Investigative Site, Tupelo, Mississippi 38801, United States

Salix Investigational Site, Kansas City, Missouri 64131, United States

Salix Investigative Site, St. Louis, Missouri 63110, United States

Salix Investigational Site, Marlton, New Jersey 08053, United States

Salix Investigational Site, New Brunswick, New Jersey 07102, United States

Salix Investigative Site, Bronx, New York 10467, United States

Salix Investigative Site, Brooklyn, New York 60153, United States

Salix Investigational Site, Flushing, New York 11040, United States

Salix Investigational Site, New York, New York 10016, United States

Salix Investigational Site, New York, New York 10032, United States

Salix Investigational Site, Rochester, New York 14642, United States

Salix Investigational Site, Asheville, North Carolina 28801, United States

Salix Investigational Site, Chapel Hill, North Carolina 27599, United States

Salix Investigational Site, Charlotte, North Carolina 28207, United States

Salix Investigative Site, Charlotte, North Carolina 28204, United States

Salix Investigational Site, Fayetteville, North Carolina 28304, United States

Salix Investigational Site, Wilmington, North Carolina 28403, United States

Salix Investigational Site, Winston-Salem, North Carolina 27103, United States

Salix Investigational Site, Cincinnati, Ohio 45249, United States

Salix Investigative Site, Cincinnati, Ohio 45224, United States

Salix Investigational Site, Cleveland, Ohio 44195, United States

Salix Investigative Site, Dayton, Ohio 45415, United States

Salix Investigational Site, Mentor, Ohio 44060, United States

Salix Investigational Site, Portland, Oregon 97210, United States

Salix Investigative Site, Bristol, Tennessee 37620, United States

Salix Investigational Site, Chattanoga, Tennessee 37421, United States

Salix Investigational Site, Nashville, Tennessee 37205, United States

Salix Investigational Site, Nashville, Tennessee 37211, United States

Salix Investigative Site, Arlington, Texas 76012, United States

Salix Investigational Site, Austin, Texas 78705, United States

Salix Investigational Site, Dallas, Texas 75203, United States

Salix Investigational Site, Dallas, Texas 75246, United States

Salix Investigative Site, Dallas, Texas 75390, United States

Salix Investigational Site, Fort Worth, Texas 76104, United States

Salix Investigational Site, Houston, Texas 77005, United States

Salix Investigational Site, Houston, Texas 77030, United States

Salix Investigational Site, Houston, Texas 77090, United States

Salix Investigational Site, San Antonio, Texas 78215, United States

Salix Investigational Site, San Antonio, Texas 78229, United States

Salix Investigational Site, Bountiful, Utah 84010, United States

Salix Investigative Site, Salt Lake City, Utah 84132, United States

Salix Investigational Site, Charlottesville, Virginia 22908, United States

Salix Investigative Site, Norfolk, Virginia 23502, United States

Salix Investigational Site, Richmond, Virginia 23298, United States

Salix Investigative Site, Richmond, Virginia 23249, United States

Salix Investigative Site, Richland, Washington 99352, United States

Salix Investigative Site, Seattle, Washington 98104, United States

Additional Information

Starting date: June 2013
Last updated: February 3, 2015

Page last updated: August 23, 2015

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