One Year Study of Rifaximin Delayed Release (DR) Tablets in Crohn's Disease
NCT ID: NCT02240121
Last Updated: 2019-09-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
80 participants
INTERVENTIONAL
2014-08-21
2017-08-16
Brief Summary
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Detailed Description
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Participants will be randomized in a 1:1 allocation to rifaximin or placebo at the beginning of the treatment period and will maintain treatment assignment throughout the duration of the study. Ileocolonoscopy will be performed on all participants at baseline, between Weeks 16 and 17 (end of the Induction Phase), and following completion of the 36-week Long Term Treatment Phase (Week 52).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rifaximin EIR 800 mg
Participants will receive rifaximin EIR 400 milligrams (mg) tablets orally twice daily for 52 weeks.
Rifaximin EIR
Rifaximin EIR tablets will be administered per the dose and schedule specified in the arm.
Placebo
Participants will receive placebo matching to rifaximin EIR tablets orally twice daily for 52 weeks.
Placebo
Placebo matching to rifaximin EIR tablets will be administered per the dose and schedule specified in the arm.
Interventions
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Rifaximin EIR
Rifaximin EIR tablets will be administered per the dose and schedule specified in the arm.
Placebo
Placebo matching to rifaximin EIR tablets will be administered per the dose and schedule specified in the arm.
Eligibility Criteria
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Inclusion Criteria
* During the screening period, the participant will need to have certain average daily scores for abdominal pain and average number of liquid/very soft stools.
Exclusion Criteria
* Diagnosis of Celiac Disease.
* Bowel surgery within 12 weeks prior to screening and/or has surgery planned or deemed likely for Crohn's disease during the study period.
* Presence of an ileostomy or colostomy.
* Known fixed symptomatic stenosis/stricture of the small or large bowel.
* Had more than one segmental colonic resection.
* Had more than 3 small bowel resections or symptoms associated with short bowel syndrome.
* Current evidence of peritonitis.
* History or evidence of colonic mucosal dysplasia.
* History or evidence of adenomatous colonic polyps that have not been removed.
* Unwilling to be tapered off corticosteroids by Week 8 or the participant is known by the Investigator to be steroid-dependent.
* Has used a biologic within 12 weeks of randomization.
* Used cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or similar drugs within 8 weeks prior to randomization.
* Had rectal administration of 5-aminosalicylic acid (5-ASA) or corticosteroid enemas/foams/ suppositories within 2 weeks prior to screening visit.
18 Years
ALL
No
Sponsors
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Salix Pharmaceuticals, Inc. a division of Bausch Health US, LLC
UNKNOWN
Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lindsey Mathew
Role: STUDY_DIRECTOR
Bausch Health Americas, Inc.
Locations
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Scottsdale, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
North Little Rock, Arkansas, United States
Bakersfield, California, United States
Los Angeles, California, United States
Mission Hills, California, United States
Orange, California, United States
San Carlos, California, United States
Torrance, California, United States
Denver, Colorado, United States
Bristol, Connecticut, United States
Danbury, Connecticut, United States
Boynton Beach, Florida, United States
Coral Springs, Florida, United States
Hialeah, Florida, United States
Homestead, Florida, United States
Largo, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Plant City, Florida, United States
Winter Haven, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Columbus, Georgia, United States
Urbana, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Pratt, Kansas, United States
Madisonville, Kentucky, United States
Chevy Chase, Maryland, United States
Towson, Maryland, United States
Marlborough, Massachusetts, United States
Ann Arbor, Michigan, United States
Chesterfield, Michigan, United States
Troy, Michigan, United States
Jackson, Mississippi, United States
Mexico, Missouri, United States
Reno, Nevada, United States
Marlton, New Jersey, United States
Teaneck, New Jersey, United States
Brooklyn, New York, United States
Flushing, New York, United States
Great Neck, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Chapel Hill, North Carolina, United States
Jacksonville, North Carolina, United States
Kinston, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Mentor, Ohio, United States
Oklahoma City, Oklahoma, United States
Sayre, Pennsylvania, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Orangeburg, South Carolina, United States
Sioux Falls, South Dakota, United States
Kingsport, Tennessee, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Fort Worth, Texas, United States
Pasadena, Texas, United States
Southlake, Texas, United States
Clinton, Utah, United States
Leesburg, Virginia, United States
Bellevue, Washington, United States
Madison, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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RECD3125
Identifier Type: -
Identifier Source: org_study_id
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