- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01543178
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
It is important in chronic conditions to have information about how a product that is intended for short course administration in order to confer prolonged benefit should be administered beyond the first cycle of use once symptoms reappear. This Phase 3 study will evaluate the efficacy and safety of repeat treatment with rifaximin 550 mg three times daily (TID) for 14 days in subjects with IBS-D who respond to an initial treatment course with rifaximin 550 mg TID for 14 days.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Berlin, Germany, 14193
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Hamburg, Germany, 22297
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Manchester, United Kingdom, M23 9LT
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Alabama
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Anniston, Alabama, United States, 36207
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Birmingham, Alabama, United States, 35235
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Birmingham, Alabama, United States, 35216
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Birmingham, Alabama, United States, 35243
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Birmingham, Alabama, United States, 35405
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Dothan, Alabama, United States, 36305
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Huntsville, Alabama, United States, 35801
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Montgomery, Alabama, United States, 36104
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Montgomery, Alabama, United States, 36109
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Selma, Alabama, United States, 37601
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Arizona
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Chandler, Arizona, United States, 85224
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Peoria, Arizona, United States, 85381
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Phoenix, Arizona, United States, 85018
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Scottsdale, Arizona, United States, 85257
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Tempe, Arizona, United States, 85282
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Tucson, Arizona, United States, 85704
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Tucson, Arizona, United States, 85712
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Tucson, Arizona, United States, 85710
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Arkansas
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Jonesboro, Arkansas, United States, 82401
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Little Rock, Arkansas, United States, 72205
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Little Rock, Arkansas, United States, 72204
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Little Rock, Arkansas, United States, 72212
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North Little Rock, Arkansas, United States, 72117
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Sherwood, Arkansas, United States, 72120
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California
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Anaheim, California, United States, 92801
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Artesia, California, United States, 90701
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Carlsbad, California, United States, 92008
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Chula Vista, California, United States, 91910
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Chula Vista, California, United States, 91911
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Concord, California, United States, 94520
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Encinitas, California, United States, 92024
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Encino, California, United States, 91436
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Escondido, California, United States, 92025
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Garden Grove, California, United States, 92845
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Garden Grove, California, United States, 92844
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Garden Grove, California, United States, 92840
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Glendale, California, United States, 91204
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Huntington Beach, California, United States, 92647
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La Mesa, California, United States, 91942
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La Mirada, California, United States, 90638
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Laguna Hills, California, United States, 92653
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Lakewood, California, United States, 90712
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Lincoln, California, United States, 95648
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Lomita, California, United States, 90717
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Long Beach, California, United States, 90806
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Long Beach, California, United States, 90813
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Los Angeles, California, United States, 90048
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Los Angeles, California, United States, 90036
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Los Angeles, California, United States, 90045
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Madera, California, United States, 93619
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Mill Valley, California, United States, 94941
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Montebello, California, United States, 90640
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North Hollywood, California, United States, 91606
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Orange, California, United States, 92868
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Redlands, California, United States, 92374
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Sacramento, California, United States, 95821
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San Carlos, California, United States, 94070
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San Diego, California, United States, 92108
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San Diego, California, United States, 92123
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San Diego, California, United States, 92114
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San Diego, California, United States, 92101
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Vista, California, United States, 92083
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Colorado
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Colorado Springs, Colorado, United States, 80920
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Colorado Springs, Colorado, United States, 90807
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Denver, Colorado, United States, 80220
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Denver, Colorado, United States, 80211
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Lakewood, Colorado, United States, 80215
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Lone Tree, Colorado, United States, 80124
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Connecticut
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Bridgeport, Connecticut, United States, 06606
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Bristol, Connecticut, United States, 06010
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Danbury, Connecticut, United States, 06810
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Torrington, Connecticut, United States, 06790
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Florida
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Boca Raton, Florida, United States, 33432
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Boca Raton, Florida, United States, 33428
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Boynton Beach, Florida, United States, 33426
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Boynton Beach, Florida, United States, 33472
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Brandon, Florida, United States, 33511
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Clearwater, Florida, United States, 33756
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Gainesville, Florida, United States, 32607
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Hialeah, Florida, United States, 33016
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Hialeah, Florida, United States, 33012
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Hialeah, Florida, United States, 33010
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Hollywood, Florida, United States, 33021
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Jupiter, Florida, United States, 33458
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Kissimmee, Florida, United States, 34741
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Lake Worth, Florida, United States, 33449
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Largo, Florida, United States, 33777
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Lauderdale Lakes, Florida, United States, 33319
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Maitland, Florida, United States, 32751
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Miami, Florida, United States, 33136
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Miami, Florida, United States, 33144
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Miami, Florida, United States, 33165
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Miami, Florida, United States, 33155
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Miami, Florida, United States, 33143
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Miami, Florida, United States, 33015
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Miami, Florida, United States, 33156
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Miami, Florida, United States, 33174
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Miami Springs, Florida, United States, 33166
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Naples, Florida, United States, 34102
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Orange Park, Florida, United States, 32073
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Orlando, Florida, United States, 32806
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Ormond Beach, Florida, United States, 32174
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Plant City, Florida, United States, 33563
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Pompano Beach, Florida, United States, 33060
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Port Orange, Florida, United States, 32127
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Saint Petersburg, Florida, United States, 33709
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Sarasota, Florida, United States, 34231
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Seminole, Florida, United States, 33777
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Tampa, Florida, United States, 33613
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Tampa, Florida, United States, 33603
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Wellington, Florida, United States, 33414
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West Palm Beach, Florida, United States, 33409
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West Palm Beach, Florida, United States, 33406
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Winter Haven, Florida, United States, 33880
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Winter Park, Florida, United States, 32789
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Zephyrhills, Florida, United States, 33542
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Georgia
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Athens, Georgia, United States, 30606
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Atlanta, Georgia, United States, 30342
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Atlanta, Georgia, United States, 30338
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Augusta, Georgia, United States, 30912
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Augusta, Georgia, United States, 30909
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Columbus, Georgia, United States, 31904
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Columbus, Georgia, United States, 31909
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Macon, Georgia, United States, 31201
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Marietta, Georgia, United States, 30060
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Norcross, Georgia, United States, 30092
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Idaho
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Boise, Idaho, United States, 83642
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Boise, Idaho, United States, 83709
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Hayden Lake, Idaho, United States, 83835
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Idaho Falls, Idaho, United States, 83406
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Illinois
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Arlington Heights, Illinois, United States, 60005
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Chicago, Illinois, United States, 60602
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Evanston, Illinois, United States, 60201
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Oak Lawn, Illinois, United States, 60453
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Indiana
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Elkhart, Indiana, United States, 46514
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Evansville, Indiana, United States, 47713
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Evansville, Indiana, United States, 47714
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Indianapolis, Indiana, United States, 46202
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Mishawaka, Indiana, United States, 46545
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Iowa
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Clive, Iowa, United States, 50325
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Iowa City, Iowa, United States, 52242
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Kansas
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Kansas City, Kansas, United States, 66160
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Overland Park, Kansas, United States, 66215
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Topeka, Kansas, United States, 66604
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Wichita, Kansas, United States, 67226
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Kentucky
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Bowling Green, Kentucky, United States, 42101
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Crestview Hills, Kentucky, United States, 41017
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Hebron, Kentucky, United States, 41048
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Lexington, Kentucky, United States, 40509
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Lexington, Kentucky, United States, 40504
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Louisville, Kentucky, United States, 40291
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Madisonville, Kentucky, United States, 42431
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Louisiana
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Metairie, Louisiana, United States, 70006
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New Orleans, Louisiana, United States, 70115
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Shreveport, Louisiana, United States, 71103
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Maryland
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Annapolis, Maryland, United States, 21401
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Baltimore, Maryland, United States, 21215
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Baltimore, Maryland, United States, 21229
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Hagerstown, Maryland, United States, 21742
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Hollywood, Maryland, United States, 20636
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Massachusetts
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Boston, Massachusetts, United States, 02135
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Brockton, Massachusetts, United States, 02302
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Marlborough, Massachusetts, United States, 01752
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Watertown, Massachusetts, United States, 02472
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Michigan
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Ann Arbor, Michigan, United States, 48109
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Kalamazoo, Michigan, United States, 49008
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Kalamazoo, Michigan, United States, 49009
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Saginaw, Michigan, United States, 48604
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Wyoming, Michigan, United States, 49519
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Mississippi
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Jackson, Mississippi, United States, 39202
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Ocean Springs, Mississippi, United States, 39564
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Missouri
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Kansas City, Missouri, United States, 64114
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Lee's Summit, Missouri, United States, 64064
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Mexico, Missouri, United States, 65265
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Saint Louis, Missouri, United States, 63141
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Saint Louis, Missouri, United States, 63104
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Saint Louis, Missouri, United States, 63122
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Montana
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Missoula, Montana, United States, 59808
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Nebraska
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Bellevue, Nebraska, United States, 68005
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Fremont, Nebraska, United States, 68025
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Omaha, Nebraska, United States, 68130
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Nevada
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Henderson, Nevada, United States, 89052
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Las Vegas, Nevada, United States, 89109
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Las Vegas, Nevada, United States, 89128
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Reno, Nevada, United States, 89511
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New Hampshire
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Lebanon, New Hampshire, United States, 05756
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Newington, New Hampshire, United States, 03801
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New Jersey
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Haddon Heights, New Jersey, United States, 08030
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Marlton, New Jersey, United States, 08053
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New Mexico
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Albuquerque, New Mexico, United States, 87102
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Albuquerque, New Mexico, United States, 87108
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New York
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Brooklyn, New York, United States, 11206
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Great Neck, New York, United States, 11021
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Great Neck, New York, United States, 11023
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Hollis, New York, United States, 11423
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Mineola, New York, United States, 39202
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New York, New York, United States, 10075
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Poughkeepsie, New York, United States, 12601
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Rochester, New York, United States, 14609
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North Carolina
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Asheboro, North Carolina, United States, 27203
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Asheville, North Carolina, United States, 28801
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Boone, North Carolina, United States, 28607
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Cary, North Carolina, United States, 27518
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Chapel Hill, North Carolina, United States, 27599
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Charlotte, North Carolina, United States, 28207
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Greensboro, North Carolina, United States, 27408
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Greensboro, North Carolina, United States, 27403
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High Point, North Carolina, United States, 27262
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Kinston, North Carolina, United States, 28501
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Raleigh, North Carolina, United States, 27613
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Salisbury, North Carolina, United States, 28144
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Wilmington, North Carolina, United States, 28479
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Winston-Salem, North Carolina, United States, 27103
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North Dakota
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Fargo, North Dakota, United States, 85103
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Ohio
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Akron, Ohio, United States, 44311
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Akron, Ohio, United States, 44302
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Centerville, Ohio, United States, 45459
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Cincinnati, Ohio, United States, 45242
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Cincinnati, Ohio, United States, 45219
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Cleveland, Ohio, United States, 44115
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Columbus, Ohio, United States, 43215
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Columbus, Ohio, United States, 43214
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Dayton, Ohio, United States, 45415
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Dayton, Ohio, United States, 45432
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Groveport, Ohio, United States, 43215
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Kettering, Ohio, United States, 45429
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Mentor, Ohio, United States, 44060
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Oklahoma
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Norman, Oklahoma, United States, 73069
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Oklahoma City, Oklahoma, United States, 73120
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Oklahoma City, Oklahoma, United States, 73103
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Tulsa, Oklahoma, United States, 74136
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Tulsa, Oklahoma, United States, 74104
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Oregon
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Medford, Oregon, United States, 97504
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Portland, Oregon, United States, 97210
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Pennsylvania
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Downingtown, Pennsylvania, United States, 19335
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Pittsburgh, Pennsylvania, United States, 15206
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Reading, Pennsylvania, United States, 19606
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Sayre, Pennsylvania, United States, 18840
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Rhode Island
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East Providence, Rhode Island, United States, 02914
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Warwick, Rhode Island, United States, 02886
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South Carolina
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Charleston, South Carolina, United States, 29407
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Charleston, South Carolina, United States, 29412
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Columbia, South Carolina, United States, 29203
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Fort Mill, South Carolina, United States, 29707
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Gaffney, South Carolina, United States, 29341
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Greer, South Carolina, United States, 29650
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Tennessee
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Brentwood, Tennessee, United States, 37027
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Bristol, Tennessee, United States, 37620
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Chattanooga, Tennessee, United States, 37421
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Franklin, Tennessee, United States, 37067
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Germantown, Tennessee, United States, 38138
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Hermitage, Tennessee, United States, 37076
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Kingsport, Tennessee, United States, 37660
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Nashville, Tennessee, United States, 37205
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Texas
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Arlington, Texas, United States, 76012
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Austin, Texas, United States, 78705
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Austin, Texas, United States, 78731
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Austin, Texas, United States, 78745
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Austin, Texas, United States, 78735
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Corsicana, Texas, United States, 75110
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Dallas, Texas, United States, 75224
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El Paso, Texas, United States, 79905
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77074
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Houston, Texas, United States, 77011
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Houston, Texas, United States, 77090
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Houston, Texas, United States, 77005
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Houston, Texas, United States, 77098
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Lake Jackson, Texas, United States, 77566
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Odessa, Texas, United States, 79761
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Pasadena, Texas, United States, 77505
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Plano, Texas, United States, 75075
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States, 78258
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San Antonio, Texas, United States, 78215
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Sealy, Texas, United States, 77474
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Southlake, Texas, United States, 76092
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Tyler, Texas, United States, 75701
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Utah
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Bountiful, Utah, United States, 84010
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Ogden, Utah, United States, 84405
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Salt Lake City, Utah, United States, 84107
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West Jordan, Utah, United States, 84088
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Virginia
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Charlottesville, Virginia, United States, 22911
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Chesapeake, Virginia, United States, 23320
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Danville, Virginia, United States, 24541
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Fairfax, Virginia, United States, 22031
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Richmond, Virginia, United States, 23225
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Suffolk, Virginia, United States, 23434
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Washington
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Bellevue, Washington, United States, 98004
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Seattle, Washington, United States, 98105
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Spokane, Washington, United States, 99208
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
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Milwaukee, Wisconsin, United States, 53215
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
550 mg three times a day (open-label)
Other Names:
|
Experimental: 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.
|
550 mg three times a day (open-label)
Other Names:
550 mg three times a day (double-blind)
Other Names:
|
Placebo Comparator: 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.
|
550 mg three times a day (open-label)
Other Names:
3 times a day (double-blind)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Repeat Treatment Responders
Time Frame: 4-week treatment-free follow-up in double-blind repeat treatment phase.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Enoch Bortey, PhD, Bausch Health Americas, Inc.
Publications and helpful links
General Publications
- 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. Erratum In: Dig Dis Sci. 2017 Sep 7;:
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RFIB3053
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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