Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study
NCT ID: NCT01543178
Last Updated: 2017-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2583 participants
INTERVENTIONAL
2012-02-29
2014-06-30
Brief Summary
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Detailed Description
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This study consists of several treatment phases outlined below:
Screening/Treatment 1 Phase. Subjects will receive single-blind placebo TID for 7-13 days and answer daily IBS symptom-related questions.
Treatment 2 Phase. Eligible subjects will receive open-label rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up. Responders will continue into Maintenance Phase 1. Nonresponders will withdraw from the study.
Maintenance Phase 1. Subjects will continue the treatment-free follow-up period for up to 18 weeks until either: 1) they experience recurrence or 2) enrollment is met in the Treatment 3 Phase (Double Blind Repeat Treatment Phase). Subjects who do not meet recurrence criteria by the end of the Maintenance Phase 1 will withdraw from the study.
Treatment 3 Phase/ Double Blind Repeat Treatment Phase. Subjects who meet criteria for recurrence will be randomized 1:1 to receive either rifaximin 550 mg TID or placebo TID for 2 weeks with a 4-week treatment-free follow-up.
Primary efficacy analysis will be performed at the end of the Treatment 3 Phase (at Week 6 of the double-blind period).
Maintenance Phase 2. All subjects continued into an additional treatment-free follow-up period of up to 6 weeks (Maintenance Phase 2).
Treatment 4 Phase/Second Repeat Treatment Phase. Subjects will receive the same double-blind treatment as previously assigned in the Treatment 3 Phase for 2 weeks with a 4-week treatment-free follow-up.
A lactulose breath test sub-study will be conducted at select sites.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Rifaximin open-label
Subjects will receive open-label rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up. Responders will continue into Maintenance Phase 1 (treatment free). Nonresponders will withdraw from the study.
Subjects who meet criteria for recurrence in Maintenance Phase 1 enter the double-blind period and are randomized 1:1 to receive rifaximin 550 mg or placebo.
open-label rifaximin
550 mg three times a day (open-label)
Double-blind rifaximin (retreatment)
Subjects in this arm receive rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks \[treatment free\]) followed by a second retreatment with rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up.
open-label rifaximin
550 mg three times a day (open-label)
double-blind rifaximin
550 mg three times a day (double-blind)
Double-blind placebo (retreatment)
Subjects in this arm receive placebo TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks \[treatment free\]) followed by a second retreatment with placebo TID for 2 weeks with a 4-week treatment-free follow-up.
open-label rifaximin
550 mg three times a day (open-label)
double-blind placebo
3 times a day (double-blind)
Interventions
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open-label rifaximin
550 mg three times a day (open-label)
double-blind placebo
3 times a day (double-blind)
double-blind rifaximin
550 mg three times a day (double-blind)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 18 years of age.
* Colonoscopy within the past 10 years to rule out inflammatory bowel disease; or flexible sigmoidoscopy if \< 50 years of age or previous colonoscopy \> 10 years prior.
* Willing to maintain a stable diet. including vitamins, supplements, and nutraceuticals.
Exclusion Criteria
* Lactose intolerance and not controlled by a lactose-free diet.
* Pregnant or planning to become pregnant or is lactating.
* History of HIV or hepatitis B or C.
* Participation in investigational study within past 30 days.
* Taking rifaximin or any other antibiotic within past 60 days.
* Unstable cardiovascular or pulmonary disease, with change in treatment in last 30 days due to worsening disease condition.
* History of GI surgery.
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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Enoch Bortey, PhD
Role: STUDY_DIRECTOR
Bausch Health Americas, Inc.
Locations
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Anniston, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Dothan, Alabama, United States
Huntsville, Alabama, United States
Montgomery, Alabama, United States
Montgomery, Alabama, United States
Selma, Alabama, United States
Chandler, Arizona, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tempe, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
North Little Rock, Arkansas, United States
Sherwood, Arkansas, United States
Anaheim, California, United States
Artesia, California, United States
Carlsbad, California, United States
Chula Vista, California, United States
Chula Vista, California, United States
Concord, California, United States
Encinitas, California, United States
Encino, California, United States
Escondido, California, United States
Garden Grove, California, United States
Garden Grove, California, United States
Garden Grove, California, United States
Glendale, California, United States
Huntington Beach, California, United States
La Mesa, California, United States
La Mirada, California, United States
Laguna Hills, California, United States
Lakewood, California, United States
Lincoln, California, United States
Lomita, California, United States
Long Beach, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Madera, California, United States
Mill Valley, California, United States
Montebello, California, United States
North Hollywood, California, United States
Orange, California, United States
Redlands, California, United States
Sacramento, California, United States
San Carlos, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
Vista, California, United States
Colorado Springs, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Denver, Colorado, United States
Lakewood, Colorado, United States
Lone Tree, Colorado, United States
Bridgeport, Connecticut, United States
Bristol, Connecticut, United States
Danbury, Connecticut, United States
Torrington, Connecticut, United States
Boca Raton, Florida, United States
Boca Raton, Florida, United States
Boynton Beach, Florida, United States
Boynton Beach, Florida, United States
Brandon, Florida, United States
Clearwater, Florida, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Jupiter, Florida, United States
Kissimmee, Florida, United States
Lake Worth, Florida, United States
Largo, 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, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Springs, Florida, United States
Naples, Florida, United States
Orange Park, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
Plant City, Florida, United States
Pompano Beach, Florida, United States
Port Orange, Florida, United States
Sarasota, Florida, United States
Seminole, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Wellington, Florida, United States
West Palm Beach, Florida, United States
West Palm Beach, Florida, United States
Winter Haven, Florida, United States
Winter Park, Florida, United States
Zephyrhills, Florida, United States
Athens, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Augusta, Georgia, United States
Columbus, Georgia, United States
Columbus, Georgia, United States
Macon, Georgia, United States
Marietta, Georgia, United States
Norcross, Georgia, United States
Boise, Idaho, United States
Boise, Idaho, United States
Hayden Lake, Idaho, United States
Idaho Falls, Idaho, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
Oak Lawn, Illinois, United States
Elkhart, Indiana, United States
Evansville, Indiana, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Mishawaka, Indiana, United States
Clive, Iowa, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Overland Park, Kansas, United States
Topeka, Kansas, United States
Wichita, Kansas, United States
Bowling Green, Kentucky, United States
Crestview Hills, Kentucky, United States
Hebron, Kentucky, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Madisonville, Kentucky, United States
Metairie, Louisiana, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Annapolis, Maryland, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Hagerstown, Maryland, United States
Hollywood, Maryland, United States
Boston, Massachusetts, United States
Brockton, Massachusetts, United States
Marlborough, Massachusetts, United States
Watertown, Massachusetts, United States
Ann Arbor, Michigan, United States
Kalamazoo, Michigan, United States
Kalamazoo, Michigan, United States
Saginaw, Michigan, United States
Wyoming, Michigan, United States
Jackson, Mississippi, United States
Ocean Springs, Mississippi, United States
Kansas City, Missouri, United States
Lee's Summit, Missouri, United States
Mexico, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Missoula, Montana, United States
Bellevue, Nebraska, United States
Fremont, Nebraska, United States
Omaha, Nebraska, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Lebanon, New Hampshire, United States
Newington, New Hampshire, United States
Haddon Heights, New Jersey, United States
Marlton, New Jersey, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
Great Neck, New York, United States
Great Neck, New York, United States
Hollis, New York, United States
Mineola, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Rochester, New York, United States
Asheboro, North Carolina, United States
Asheville, North Carolina, United States
Boone, North Carolina, United States
Cary, North Carolina, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
Greensboro, North Carolina, United States
High Point, North Carolina, United States
Kinston, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Akron, Ohio, United States
Akron, Ohio, United States
Centerville, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Dayton, Ohio, United States
Groveport, Ohio, United States
Kettering, Ohio, United States
Mentor, Ohio, United States
Norman, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Portland, Oregon, United States
Downingtown, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Reading, Pennsylvania, United States
Sayre, Pennsylvania, United States
East Providence, Rhode Island, United States
Warwick, Rhode Island, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Fort Mill, South Carolina, United States
Gaffney, South Carolina, United States
Greer, South Carolina, United States
Brentwood, Tennessee, United States
Bristol, Tennessee, United States
Chattanooga, Tennessee, United States
Franklin, Tennessee, United States
Germantown, Tennessee, United States
Hermitage, Tennessee, United States
Kingsport, Tennessee, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
Corsicana, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Lake Jackson, Texas, United States
Odessa, Texas, United States
Pasadena, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Sealy, Texas, United States
Southlake, Texas, United States
Tyler, Texas, United States
Bountiful, Utah, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Charlottesville, Virginia, United States
Chesapeake, Virginia, United States
Danville, Virginia, United States
Fairfax, Virginia, United States
Richmond, Virginia, United States
Suffolk, Virginia, United States
Bellevue, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Milwaukee, Wisconsin, United States
Milwaukee, Wisconsin, United States
Berlin, , Germany
Hamburg, , Germany
Manchester, , United Kingdom
Countries
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References
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Lacy BE, Chang L, Rao SSC, Heimanson Z, Sayuk GS. Rifaximin Treatment for Individual and Multiple Symptoms of Irritable Bowel Syndrome With Diarrhea: An Analysis Using New End Points. Clin Ther. 2023 Mar;45(3):198-209. doi: 10.1016/j.clinthera.2023.01.010. Epub 2023 Mar 14.
Fodor AA, Pimentel M, Chey WD, Lembo A, Golden PL, Israel RJ, Carroll IM. Rifaximin is associated with modest, transient decreases in multiple taxa in the gut microbiota of patients with diarrhoea-predominant irritable bowel syndrome. Gut Microbes. 2019;10(1):22-33. doi: 10.1080/19490976.2018.1460013. Epub 2018 Jul 18.
Cash BD, Pimentel M, Rao SSC, Weinstock L, Chang L, Heimanson Z, Lembo A. Repeat treatment with rifaximin improves irritable bowel syndrome-related quality of life: a secondary analysis of a randomized, double-blind, placebo-controlled trial. Therap Adv Gastroenterol. 2017 Sep;10(9):689-699. doi: 10.1177/1756283X17726087. Epub 2017 Sep 11.
Pimentel M, Cash BD, Lembo A, Wolf RA, Israel RJ, Schoenfeld P. Repeat Rifaximin for Irritable Bowel Syndrome: No Clinically Significant Changes in Stool Microbial Antibiotic Sensitivity. Dig Dis Sci. 2017 Sep;62(9):2455-2463. doi: 10.1007/s10620-017-4598-7. Epub 2017 Jun 6.
DuPont HL, Wolf RA, Israel RJ, Pimentel M. Antimicrobial Susceptibility of Staphylococcus Isolates from the Skin of Patients with Diarrhea-Predominant Irritable Bowel Syndrome Treated with Repeat Courses of Rifaximin. Antimicrob Agents Chemother. 2016 Dec 27;61(1):e02165-16. doi: 10.1128/AAC.02165-16. Print 2017 Jan. No abstract available.
Lembo A, Pimentel M, Rao SS, Schoenfeld P, Cash B, Weinstock LB, Paterson C, Bortey E, Forbes WP. Repeat Treatment With Rifaximin Is Safe and Effective in Patients With Diarrhea-Predominant Irritable Bowel Syndrome. Gastroenterology. 2016 Dec;151(6):1113-1121. doi: 10.1053/j.gastro.2016.08.003. Epub 2016 Aug 13.
Other Identifiers
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RFIB3053
Identifier Type: -
Identifier Source: org_study_id
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