Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study
TARGET3
A Study to Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 mg TID in Subjects With Irritable Bowel Syndrome With Diarrhea (IBS-D)
1 other identifier
interventional
2,583
3 countries
296
Brief Summary
This study will evaluate the effectiveness and safety of repeat treatment with rifaximin 550 mg three times a day in patients with IBS with diarrhea who respond to initial treatment of rifaximin 550 mg three times a day.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2012
296 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 27, 2012
CompletedFirst Posted
Study publicly available on registry
March 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
July 8, 2015
CompletedDecember 12, 2017
December 1, 2017
2.3 years
February 27, 2012
June 15, 2015
December 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Repeat Treatment Responders
Subjects who respond to repeat treatment in both IBS-related abdominal pain and stool consistency. The proportion of patients who responded to repeat treatment during the first double-blind repeat treatment phase is presented. Response is defined as improvement from baseline in abdominal pain AND reduction from baseline in diarrhea.
4-week treatment-free follow-up in double-blind repeat treatment phase.
Study Arms (3)
Rifaximin open-label
EXPERIMENTALSubjects 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.
Double-blind rifaximin (retreatment)
EXPERIMENTALSubjects 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.
Double-blind placebo (retreatment)
PLACEBO COMPARATORSubjects 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.
Interventions
550 mg three times a day (open-label)
3 times a day (double-blind)
550 mg three times a day (double-blind)
Eligibility Criteria
You may qualify if:
- IBS confirmed by Rome III diagnostic 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.
You may not qualify if:
- Diabetes (Type 1 or 2).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (296)
Unknown Facility
Anniston, Alabama, 36207, United States
Unknown Facility
Birmingham, Alabama, 35216, United States
Unknown Facility
Birmingham, Alabama, 35235, United States
Unknown Facility
Birmingham, Alabama, 35243, United States
Unknown Facility
Birmingham, Alabama, 35405, United States
Unknown Facility
Dothan, Alabama, 36305, United States
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Montgomery, Alabama, 36104, United States
Unknown Facility
Montgomery, Alabama, 36109, United States
Unknown Facility
Selma, Alabama, 37601, United States
Unknown Facility
Chandler, Arizona, 85224, United States
Unknown Facility
Peoria, Arizona, 85381, United States
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Phoenix, Arizona, 85018, United States
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Scottsdale, Arizona, 85257, United States
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Tempe, Arizona, 85282, United States
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Tucson, Arizona, 85704, United States
Unknown Facility
Tucson, Arizona, 85710, United States
Unknown Facility
Tucson, Arizona, 85712, United States
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Jonesboro, Arkansas, 82401, United States
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Little Rock, Arkansas, 72204, United States
Unknown Facility
Little Rock, Arkansas, 72205, United States
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Little Rock, Arkansas, 72212, United States
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North Little Rock, Arkansas, 72117, United States
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Sherwood, Arkansas, 72120, United States
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Anaheim, California, 92801, United States
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Artesia, California, 90701, United States
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Carlsbad, California, 92008, United States
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Chula Vista, California, 91910, United States
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Chula Vista, California, 91911, United States
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Concord, California, 94520, United States
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Encinitas, California, 92024, United States
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Encino, California, 91436, United States
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Escondido, California, 92025, United States
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Garden Grove, California, 92840, United States
Unknown Facility
Garden Grove, California, 92844, United States
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Garden Grove, California, 92845, United States
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Glendale, California, 91204, United States
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Huntington Beach, California, 92647, United States
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La Mesa, California, 91942, United States
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La Mirada, California, 90638, United States
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Laguna Hills, California, 92653, United States
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Lakewood, California, 90712, United States
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Lincoln, California, 95648, United States
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Lomita, California, 90717, United States
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Long Beach, California, 90806, United States
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Long Beach, California, 90813, United States
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Los Angeles, California, 90036, United States
Unknown Facility
Los Angeles, California, 90045, United States
Unknown Facility
Los Angeles, California, 90048, United States
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Madera, California, 93619, United States
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Mill Valley, California, 94941, United States
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Montebello, California, 90640, United States
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North Hollywood, California, 91606, United States
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Orange, California, 92868, United States
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Redlands, California, 92374, United States
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Sacramento, California, 95821, United States
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San Carlos, California, 94070, United States
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San Diego, California, 92101, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
San Diego, California, 92114, United States
Unknown Facility
San Diego, California, 92123, United States
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Vista, California, 92083, United States
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Colorado Springs, Colorado, 80920, United States
Unknown Facility
Colorado Springs, Colorado, 90807, United States
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Denver, Colorado, 80211, United States
Unknown Facility
Denver, Colorado, 80220, United States
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Lakewood, Colorado, 80215, United States
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Lone Tree, Colorado, 80124, United States
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Bridgeport, Connecticut, 06606, United States
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Bristol, Connecticut, 06010, United States
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Danbury, Connecticut, 06810, United States
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Torrington, Connecticut, 06790, United States
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Boca Raton, Florida, 33428, United States
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Boca Raton, Florida, 33432, United States
Unknown Facility
Boynton Beach, Florida, 33426, United States
Unknown Facility
Boynton Beach, Florida, 33472, United States
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Brandon, Florida, 33511, United States
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Clearwater, Florida, 33756, United States
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Gainesville, Florida, 32607, United States
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Hialeah, Florida, 33010, United States
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Hialeah, Florida, 33012, United States
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Hialeah, Florida, 33016, United States
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Hollywood, Florida, 33021, United States
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Jupiter, Florida, 33458, United States
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Kissimmee, Florida, 34741, United States
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Lake Worth, Florida, 33449, United States
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Largo, Florida, 33777, United States
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Lauderdale Lakes, Florida, 33319, United States
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Maitland, Florida, 32751, United States
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Miami, Florida, 33015, United States
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Miami, Florida, 33136, United States
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Miami, Florida, 33143, United States
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Miami, Florida, 33144, United States
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Miami, Florida, 33155, United States
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Miami, Florida, 33156, United States
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Miami, Florida, 33165, United States
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Miami, Florida, 33174, United States
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Miami Springs, Florida, 33166, United States
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Naples, Florida, 34102, United States
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Orange Park, Florida, 32073, United States
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Orlando, Florida, 32806, United States
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Ormond Beach, Florida, 32174, United States
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Plant City, Florida, 33563, United States
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Pompano Beach, Florida, 33060, United States
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Port Orange, Florida, 32127, United States
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Sarasota, Florida, 34231, United States
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Seminole, Florida, 33777, United States
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St. Petersburg, Florida, 33709, United States
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Tampa, Florida, 33603, United States
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Tampa, Florida, 33613, United States
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Wellington, Florida, 33414, United States
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West Palm Beach, Florida, 33406, United States
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West Palm Beach, Florida, 33409, United States
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Winter Haven, Florida, 33880, United States
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Winter Park, Florida, 32789, United States
Unknown Facility
Zephyrhills, Florida, 33542, United States
Unknown Facility
Athens, Georgia, 30606, United States
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Atlanta, Georgia, 30338, United States
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Atlanta, Georgia, 30342, United States
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Augusta, Georgia, 30909, United States
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Augusta, Georgia, 30912, United States
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Columbus, Georgia, 31904, United States
Unknown Facility
Columbus, Georgia, 31909, United States
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Macon, Georgia, 31201, United States
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Marietta, Georgia, 30060, United States
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Norcross, Georgia, 30092, United States
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Boise, Idaho, 83642, United States
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Boise, Idaho, 83709, United States
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Hayden Lake, Idaho, 83835, United States
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Idaho Falls, Idaho, 83406, United States
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Arlington Heights, Illinois, 60005, United States
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Chicago, Illinois, 60602, United States
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Evanston, Illinois, 60201, United States
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Oak Lawn, Illinois, 60453, United States
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Elkhart, Indiana, 46514, United States
Unknown Facility
Evansville, Indiana, 47713, United States
Unknown Facility
Evansville, Indiana, 47714, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Mishawaka, Indiana, 46545, United States
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Clive, Iowa, 50325, United States
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Iowa City, Iowa, 52242, United States
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Kansas City, Kansas, 66160, United States
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Overland Park, Kansas, 66215, United States
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Topeka, Kansas, 66604, United States
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Wichita, Kansas, 67226, United States
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Bowling Green, Kentucky, 42101, United States
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Crestview Hills, Kentucky, 41017, United States
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Hebron, Kentucky, 41048, United States
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Lexington, Kentucky, 40504, United States
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Lexington, Kentucky, 40509, United States
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Louisville, Kentucky, 40291, United States
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Madisonville, Kentucky, 42431, United States
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Metairie, Louisiana, 70006, United States
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New Orleans, Louisiana, 70115, United States
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Shreveport, Louisiana, 71103, United States
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Annapolis, Maryland, 21401, United States
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Baltimore, Maryland, 21215, United States
Unknown Facility
Baltimore, Maryland, 21229, United States
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Hagerstown, Maryland, 21742, United States
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Hollywood, Maryland, 20636, United States
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Boston, Massachusetts, 02135, United States
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Brockton, Massachusetts, 02302, United States
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Marlborough, Massachusetts, 01752, United States
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Watertown, Massachusetts, 02472, United States
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Ann Arbor, Michigan, 48109, United States
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Kalamazoo, Michigan, 49008, United States
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Kalamazoo, Michigan, 49009, United States
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Saginaw, Michigan, 48604, United States
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Wyoming, Michigan, 49519, United States
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Jackson, Mississippi, 39202, United States
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Ocean Springs, Mississippi, 39564, United States
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Kansas City, Missouri, 64114, United States
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Lee's Summit, Missouri, 64064, United States
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Mexico, Missouri, 65265, United States
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St Louis, Missouri, 63104, United States
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St Louis, Missouri, 63122, United States
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St Louis, Missouri, 63141, United States
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Missoula, Montana, 59808, United States
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Bellevue, Nebraska, 68005, United States
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Fremont, Nebraska, 68025, United States
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Omaha, Nebraska, 68130, United States
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Henderson, Nevada, 89052, United States
Unknown Facility
Las Vegas, Nevada, 89109, United States
Unknown Facility
Las Vegas, Nevada, 89128, United States
Unknown Facility
Reno, Nevada, 89511, United States
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Lebanon, New Hampshire, 05756, United States
Unknown Facility
Newington, New Hampshire, 03801, United States
Unknown Facility
Haddon Heights, New Jersey, 08030, United States
Unknown Facility
Marlton, New Jersey, 08053, United States
Unknown Facility
Albuquerque, New Mexico, 87102, United States
Unknown Facility
Albuquerque, New Mexico, 87108, United States
Unknown Facility
Brooklyn, New York, 11206, United States
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Great Neck, New York, 11021, United States
Unknown Facility
Great Neck, New York, 11023, United States
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Hollis, New York, 11423, United States
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Mineola, New York, 39202, United States
Unknown Facility
New York, New York, 10075, United States
Unknown Facility
Poughkeepsie, New York, 12601, United States
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Rochester, New York, 14609, United States
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Asheboro, North Carolina, 27203, United States
Unknown Facility
Asheville, North Carolina, 28801, United States
Unknown Facility
Boone, North Carolina, 28607, United States
Unknown Facility
Cary, North Carolina, 27518, United States
Unknown Facility
Chapel Hill, North Carolina, 27599, United States
Unknown Facility
Charlotte, North Carolina, 28207, United States
Unknown Facility
Greensboro, North Carolina, 27403, United States
Unknown Facility
Greensboro, North Carolina, 27408, United States
Unknown Facility
High Point, North Carolina, 27262, United States
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Kinston, North Carolina, 28501, United States
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Raleigh, North Carolina, 27613, United States
Unknown Facility
Salisbury, North Carolina, 28144, United States
Unknown Facility
Wilmington, North Carolina, 28479, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
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Fargo, North Dakota, 85103, United States
Unknown Facility
Akron, Ohio, 44302, United States
Unknown Facility
Akron, Ohio, 44311, United States
Unknown Facility
Centerville, Ohio, 45459, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Cleveland, Ohio, 44115, United States
Unknown Facility
Columbus, Ohio, 43214, United States
Unknown Facility
Columbus, Ohio, 43215, United States
Unknown Facility
Dayton, Ohio, 45415, United States
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Dayton, Ohio, 45432, United States
Unknown Facility
Groveport, Ohio, 43215, United States
Unknown Facility
Kettering, Ohio, 45429, United States
Unknown Facility
Mentor, Ohio, 44060, United States
Unknown Facility
Norman, Oklahoma, 73069, United States
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Oklahoma City, Oklahoma, 73103, United States
Unknown Facility
Oklahoma City, Oklahoma, 73120, United States
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Tulsa, Oklahoma, 74104, United States
Unknown Facility
Tulsa, Oklahoma, 74136, United States
Unknown Facility
Medford, Oregon, 97504, United States
Unknown Facility
Portland, Oregon, 97210, United States
Unknown Facility
Downingtown, Pennsylvania, 19335, United States
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Pittsburgh, Pennsylvania, 15206, United States
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Reading, Pennsylvania, 19606, United States
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Sayre, Pennsylvania, 18840, United States
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East Providence, Rhode Island, 02914, United States
Unknown Facility
Warwick, Rhode Island, 02886, United States
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Charleston, South Carolina, 29407, United States
Unknown Facility
Charleston, South Carolina, 29412, United States
Unknown Facility
Columbia, South Carolina, 29203, United States
Unknown Facility
Fort Mill, South Carolina, 29707, United States
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Gaffney, South Carolina, 29341, United States
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Greer, South Carolina, 29650, United States
Unknown Facility
Brentwood, Tennessee, 37027, United States
Unknown Facility
Bristol, Tennessee, 37620, United States
Unknown Facility
Chattanooga, Tennessee, 37421, United States
Unknown Facility
Franklin, Tennessee, 37067, United States
Unknown Facility
Germantown, Tennessee, 38138, United States
Unknown Facility
Hermitage, Tennessee, 37076, United States
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Kingsport, Tennessee, 37660, United States
Unknown Facility
Nashville, Tennessee, 37205, United States
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Arlington, Texas, 76012, United States
Unknown Facility
Austin, Texas, 78705, United States
Unknown Facility
Austin, Texas, 78731, United States
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Austin, Texas, 78735, United States
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Austin, Texas, 78745, United States
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Corsicana, Texas, 75110, United States
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Dallas, Texas, 75224, United States
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El Paso, Texas, 79905, United States
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Houston, Texas, 77005, United States
Unknown Facility
Houston, Texas, 77011, United States
Unknown Facility
Houston, Texas, 77030, United States
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Houston, Texas, 77074, United States
Unknown Facility
Houston, Texas, 77090, United States
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Houston, Texas, 77098, United States
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Lake Jackson, Texas, 77566, United States
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Odessa, Texas, 79761, United States
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Pasadena, Texas, 77505, United States
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Plano, Texas, 75075, United States
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San Antonio, Texas, 78215, United States
Unknown Facility
San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78258, United States
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Sealy, Texas, 77474, United States
Unknown Facility
Southlake, Texas, 76092, United States
Unknown Facility
Tyler, Texas, 75701, United States
Unknown Facility
Bountiful, Utah, 84010, United States
Unknown Facility
Ogden, Utah, 84405, United States
Unknown Facility
Salt Lake City, Utah, 84107, United States
Unknown Facility
West Jordan, Utah, 84088, United States
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Charlottesville, Virginia, 22911, United States
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Chesapeake, Virginia, 23320, United States
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Danville, Virginia, 24541, United States
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Fairfax, Virginia, 22031, United States
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Richmond, Virginia, 23225, United States
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Suffolk, Virginia, 23434, United States
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Bellevue, Washington, 98004, United States
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Seattle, Washington, 98105, United States
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Spokane, Washington, 99208, United States
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Milwaukee, Wisconsin, 53215, United States
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Milwaukee, Wisconsin, 53226, United States
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Berlin, 14193, Germany
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Hamburg, 22297, Germany
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Manchester, M23 9LT, United Kingdom
Related Publications (6)
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.
PMID: 36922331DERIVEDFodor 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.
PMID: 29708822DERIVEDCash 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.
PMID: 28932270DERIVEDPimentel 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.
PMID: 28589238DERIVEDDuPont 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.
PMID: 27795384DERIVEDLembo 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.
PMID: 27528177DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Sorscher
- Organization
- Salix
Study Officials
- STUDY DIRECTOR
Enoch Bortey, PhD
Bausch Health Americas, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2012
First Posted
March 2, 2012
Study Start
February 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
December 12, 2017
Results First Posted
July 8, 2015
Record last verified: 2017-12