One Year Study of Rifaximin Delayed Release (DR) in Crohn's Disease
NCT ID: NCT02240108
Last Updated: 2019-09-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
81 participants
INTERVENTIONAL
2014-10-28
2017-10-06
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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Huntsville, Alabama, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Sherwood, Arkansas, United States
Garden Grove, California, United States
La Jolla, California, United States
La Mirada, California, United States
Laguna Hills, California, United States
Los Angeles, California, United States
Northridge, California, United States
Oceanside, California, United States
San Diego, California, United States
Littleton, Colorado, United States
Waterbury, Connecticut, United States
Boca Raton, Florida, United States
Clearwater, Florida, United States
Coral Gables, Florida, United States
Hollywood, Florida, United States
Inverness, Florida, United States
Lauderdale Lakes, Florida, United States
Maitland, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Springs, Florida, United States
Orange Park, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
Port Orange, Florida, United States
Tampa, Florida, United States
Athens, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
Iowa City, Iowa, United States
Crestview Hills, Kentucky, United States
Shreveport, Louisiana, United States
West Monroe, Louisiana, United States
Hagerstown, Maryland, United States
Hollywood, Maryland, United States
Brockton, Massachusetts, United States
Caro, Michigan, United States
Stevensville, Michigan, United States
Wyoming, Michigan, United States
Plymouth, Minnesota, United States
Ocean Springs, Mississippi, United States
Tupelo, Mississippi, United States
Bridgeton, Missouri, United States
Creve Coeur, Missouri, United States
Vineland, New Jersey, United States
Voorhees Township, New Jersey, United States
New York, New York, United States
New York, New York, United States
Fayetteville, North Carolina, United States
Kinston, North Carolina, United States
Beavercreek, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Kettering, Ohio, United States
Lima, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Columbia, South Carolina, United States
Fort Mill, South Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Humble, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Ogden, Utah, United States
West Jordan, Utah, United States
West Valley City, Utah, United States
Chesapeake, Virginia, United States
Richland, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RECD3126
Identifier Type: -
Identifier Source: org_study_id
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