Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study (TARGET3)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01543178
First received: February 27, 2012
Last updated: February 20, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome With Diarrhea
Drug: rifaximin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 mg TID in Subjects With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Repeat Treatment Responders [ Time Frame: 4-week treatment-free follow-up in double-blind repeat treatment phase. ] [ Designated as safety issue: No ]
    Subjects who respond to repeat treatment in both IBS-related abdominal pain and stool consistency.


Estimated Enrollment: 800
Study Start Date: February 2012
Arms Assigned Interventions
Placebo Comparator: placebo
Placebo
Drug: placebo
3 times a day
Other Name: Placebo
Experimental: rifaximin
rifaximin 550 mg
Drug: rifaximin
550 mg three times a day
Other Name: rifaximin

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 study drug 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. Non-responders 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 after 6 weeks (end of the Treatment 3 Phase).

Maintenance Phase 2. All subjects will be eligible for Maintenance Phase 2 and will continue with an additional treatment-free follow-up period of up to 6 weeks.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. IBS confirmed by Rome III diagnostic criteria
  2. At least 18 years of age
  3. Colonoscopy within the past 10 years to rule out inflammatory bowel disease or flexible sigmoidoscopy if < 50 years of age or colonoscopy > 10 years prior.
  4. Willing to maintain a stable diet. including vitamins, supplements and nutraceuticals.

Exclusion Criteria:

  1. Diabetes (Type 1 or 2)
  2. Lactose intolerance and not controlled by a lactose-free diet
  3. Pregnant or planning to become pregnant or is lactating
  4. History of HIV or hepatitis B or C
  5. Participation in investigational study within past 30 days
  6. Taking rifaximin or any other antibiotic within past 60 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543178

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Locations
United States, Alabama
Anniston, Alabama, United States, 36207
Birmingham, Alabama, United States, 35243
Birmingham, Alabama, United States, 35216
Birmingham, Alabama, United States, 35405
Birmingham, Alabama, United States, 35235
Dothan, Alabama, United States, 36305
Huntsville, Alabama, United States, 35801
Montgomery, Alabama, United States, 36109
Montgomery, Alabama, United States, 36104
Selma, Alabama, United States, 37601
United States, Arizona
Chandler, Arizona, United States, 85224
Peoria, Arizona, United States, 85381
Phoenix, Arizona, United States, 85018
Scottsdale, Arizona, United States, 85257
Tempe, Arizona, United States, 85282
Tucson, Arizona, United States, 85710
Tucson, Arizona, United States, 85704
Tucson, Arizona, United States, 85712
United States, Arkansas
Jonesboro, Arkansas, United States, 82401
Little Rock, Arkansas, United States, 72205
Little Rock, Arkansas, United States, 72204
Little Rock, Arkansas, United States, 72212
North Little Rock, Arkansas, United States, 72117
Sherwood, Arkansas, United States, 72120
United States, California
Anaheim, California, United States, 92801
Artesia, California, United States, 90701
Carlsbad, California, United States, 92008
Chula Vista, California, United States, 91910
Chula Vista, California, United States, 91911
Concord, California, United States, 94520
Encinitas, California, United States, 92024
Encino, California, United States, 91436
Escondido, California, United States, 92025
Garden Grove, California, United States, 92845
Garden Grove, California, United States, 92840
Garden Grove, California, United States, 92844
Glendale, California, United States, 91204
Huntington Beach, California, United States, 92647
La Mesa, California, United States, 91942
La Mirada, California, United States, 90638
Laguna Hills, California, United States, 92653
Lakewood, California, United States, 90712
Lincoln, California, United States, 95648
Lomita, California, United States, 90717
Long Beach, California, United States, 90813
Long Beach, California, United States, 90806
Los Angeles, California, United States, 90045
Los Angeles, California, United States, 90048
Los Angeles, California, United States, 90036
Madera, California, United States, 93619
Mill Valley, California, United States, 94941
Montebello, California, United States, 90640
North Hollywood, California, United States, 91606
Orange, California, United States, 92868
Redlands, California, United States, 92374
Sacramento, California, United States, 95821
San Carlos, California, United States, 94070
San Diego, California, United States, 92108
San Diego, California, United States, 92101
San Diego, California, United States, 92123
San Diego, California, United States, 92114
Vista, California, United States, 92083
United States, Colorado
Colorado Springs, Colorado, United States, 80920
Colorado Springs, Colorado, United States, 90807
Denver, Colorado, United States, 80211
Denver, Colorado, United States, 80220
Lakewood, Colorado, United States, 80215
Lone Tree, Colorado, United States, 80124
United States, Connecticut
Bridgeport, Connecticut, United States, 06606
Bristol, Connecticut, United States, 06010
Danbury, Connecticut, United States, 06810
Torrington, Connecticut, United States, 06790
United States, Florida
Boca Raton, Florida, United States, 33428
Boca Raton, Florida, United States, 33432
Boynton, Florida, United States, 33426
Boynton Beach, Florida, United States, 33472
Brandon, Florida, United States, 33511
Clearwater, Florida, United States, 33756
Gainesville, Florida, United States, 32607
Hialeah, Florida, United States, 33012
Hialeah, Florida, United States, 33010
Hialeah, Florida, United States, 33016
Hollywood, Florida, United States, 33021
Jupiter, Florida, United States, 33458
Kissimmee, Florida, United States, 34741
Lake Worth, Florida, United States, 33449
Largo, Florida, United States, 33777
Lauderdale Lakes, Florida, United States, 33319
Maitland, Florida, United States, 32751
Miami, Florida, United States, 33155
Miami, Florida, United States, 33136
Miami, Florida, United States, 33174
Miami, Florida, United States, 33143
Miami, Florida, United States, 33156
Miami, Florida, United States, 33015
Miami, Florida, United States, 33165
Miami, Florida, United States, 33144
Miami Springs, Florida, United States, 33166
Naples, Florida, United States, 34102
Orange Park, Florida, United States, 32073
Orlando, Florida, United States, 32806
Ormond Beach, Florida, United States, 32174
Plant City, Florida, United States, 33563
Pompano Beach, Florida, United States, 33060
Port Orange, Florida, United States, 32127
Sarasota, Florida, United States, 34231
Seminole, Florida, United States, 33777
St. Petersburg, Florida, United States, 33709
Tampa, Florida, United States, 33613
Tampa, Florida, United States, 33603
Wellington, Florida, United States, 33414
West Palm Beach, Florida, United States, 33406
West Palm Beach, Florida, United States, 33409
Winter Haven, Florida, United States, 33880
Winter Park, Florida, United States, 32789
Zephyrhills,, Florida, United States, 33542
United States, Georgia
Athens, Georgia, United States, 30606
Atlanta, Georgia, United States, 30338
Atlanta, Georgia, United States, 30342
Augusta, Georgia, United States, 30909
Augusta, Georgia, United States, 30912
Columbus, Georgia, United States, 31904
Columbus, Georgia, United States, 31909
Macon, Georgia, United States, 31201
Marietta, Georgia, United States, 30060
Norcross, Georgia, United States, 30092
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Boise, Idaho, United States, 83642
Boise, Idaho, United States, 83709
Hayden Lake, Idaho, United States, 83835
Idaho Falls, Idaho, United States, 83406
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Arlington Heights, Illinois, United States, 60005
Chicago, Illinois, United States, 60602
Evanston, Illinois, United States, 60201
Oak Lawn, Illinois, United States, 60453
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Anderson, Indiana, United States, 46-16
Elkhart, Indiana, United States, 46514
Evansville, Indiana, United States, 47714
Evansville, Indiana, United States, 47713
Indianapolis, Indiana, United States, 46202
Mishawaka, Indiana, United States, 46545
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Clive, Iowa, United States, 50325
Iowa City, Iowa, United States, 52242
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Kansas City, Kansas, United States, 66160
Overland Park, Kansas, United States, 66215
Topeka, Kansas, United States, 66604
Wichita, Kansas, United States, 67226
United States, Kentucky
Bowling Green, Kentucky, United States, 42101
Crestview Hills, Kentucky, United States, 41017
Hebron, Kentucky, United States, 41048
Lexington, Kentucky, United States, 40504
Lexington, Kentucky, United States, 40509
Louisville, Kentucky, United States, 40291
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Metairie, Louisiana, United States, 70006
New Orleans, Louisiana, United States, 70115
Shreveport, Louisiana, United States, 71103
United States, Maryland
Annapolis, Maryland, United States, 21401
Baltimore, Maryland, United States, 21229
Baltimore, Maryland, United States, 21215
Hagerstown, Maryland, United States, 21742
Hollywood, Maryland, United States, 20636
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Boston, Massachusetts, United States, 02135
Brockton, Massachusetts, United States, 02302
Marlborough, Massachusetts, United States, 01752
Watertown, Massachusetts, United States, 02472
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Ann Arbor, Michigan, United States, 48109
Kalamazoo, Michigan, United States, 49009
Kalamazoo, Michigan, United States, 49008
Saginaw, Michigan, United States, 48604
Wyoming, Michigan, United States, 49519
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Jackson, Mississippi, United States, 39202
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Kansas City, Missouri, United States, 64114
Lee's Summit, Missouri, United States, 64064
Mexico, Missouri, United States, 65265
Ocean Springs, Missouri, United States, 39564
St. Louis, Missouri, United States, 63122
St. Louis, Missouri, United States, 63104
St. Louis, Missouri, United States, 63141
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Missoula, Montana, United States, 59808
United States, Nebraska
Bellevue, Nebraska, United States, 68005
Fremont, Nebraska, United States, 68025
Omaha, Nebraska, United States, 68130
United States, Nevada
Henderson, Nevada, United States, 89052
Las Vegas, Nevada, United States, 89109
Las Vegas, Nevada, United States, 89128
Reno, Nevada, United States, 89511
United States, New Hampshire
Lebanon, New Hampshire, United States, 05756
Newington, New Hampshire, United States, 03801
United States, New Jersey
Haddon Heights, New Jersey, United States, 08030
Marlton, New Jersey, United States, 08053
United States, New Mexico
Albuquerque, New Mexico, United States, 87102
Albuquerque, New Mexico, United States, 87108
United States, New York
Brooklyn, New York, United States, 11206
Great Neck, New York, United States, 11023
Greg Neck, New York, United States, 11021
Hollis, New York, United States, 11423
Mineola, New York, United States, 39202
New York, New York, United States, 10075
Poughkeepsie, New York, United States, 12601
Rochester, New York, United States, 14609
United States, North Carolina
Asheboro, North Carolina, United States, 27203
Asheville, North Carolina, United States, 28801
Boone, North Carolina, United States, 28607
Cary, North Carolina, United States, 27518
Chapel Hill, North Carolina, United States, 27599
Charlotte, North Carolina, United States, 28207
Greensboro, North Carolina, United States, 27403
Greensboro, North Carolina, United States, 27408
High Point, North Carolina, United States, 27262
Kinston, North Carolina, United States, 28501
Raleigh, North Carolina, United States, 27613
Salisbury, North Carolina, United States, 28144
Wilmington, North Carolina, United States, 28479
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Fargo, North Dakota, United States, 85103
United States, Ohio
Akron, Ohio, United States, 44311
Akron, Ohio, United States, 44302
Centerville, Ohio, United States, 45459
Cincinnati, Ohio, United States, 45242
Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44115
Columbus, Ohio, United States, 43215
Columbus, Ohio, United States, 43214
Dayton, Ohio, United States, 45415
Dayton, Ohio, United States, 45432
Groveport, Ohio, United States, 43215
Ketttering, Ohio, United States, 45429
Mentor, Ohio, United States, 44060
United States, Oklahoma
Norman, Oklahoma, United States, 73069
Oklahoma City, Oklahoma, United States, 73103
Oklahoma City, Oklahoma, United States, 73120
Tulsa, Oklahoma, United States, 74136
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Medford, Oregon, United States, 97504
Portland, Oregon, United States, 97210
United States, Pennsylvania
Downington, Pennsylvania, United States, 19335
Pittsburgh, Pennsylvania, United States, 15206
Reading, Pennsylvania, United States, 19606
Sayre, Pennsylvania, United States, 18840
United States, Rhode Island
East Providence, Rhode Island, United States, 02914
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Charleston, South Carolina, United States, 29412
Charleston, South Carolina, United States, 29407
Columbia, South Carolina, United States, 29203
Fort Mill, South Carolina, United States, 29707
Gaffney, South Carolina, United States, 29341
Greer, South Carolina, United States, 29650
United States, Tennessee
Brentwood, Tennessee, United States, 37027
Bristol, Tennessee, United States, 37620
Chattanooga, Tennessee, United States, 37421
Franklin, Tennessee, United States, 37067
Germantown, Tennessee, United States, 38138
Hermitage, Tennessee, United States, 37076
Kingsport, Tennessee, United States, 37660
Nashville, Tennessee, United States, 37205
United States, Texas
Arlington, Texas, United States, 76012
Austin, Texas, United States, 78735
Austin, Texas, United States, 78705
Austin, Texas, United States, 78745
Austin, Texas, United States, 78731
Cosicana, Texas, United States, 75110
Dallas, Texas, United States, 75224
El Paso, Texas, United States, 79905
Houston, Texas, United States, 77090
Houston, Texas, United States, 77005
Houston, Texas, United States, 77074
Houston, Texas, United States, 77011
Houston, Texas, United States, 77030
Houston, Texas, United States, 77098
Lake Jackson, Texas, United States, 77566
Odessa, Texas, United States, 79761
Pasadena, Texas, United States, 77505
Plano, Texas, United States, 75075
San Antonio, Texas, United States, 78258
San Antonio, Texas, United States, 78215
San Antonio, Texas, United States, 78229
Sealy, Texas, United States, 77474
Southlake, Texas, United States, 76092
Tyler, Texas, United States, 75701
United States, Utah
Bountiful, Utah, United States, 84010
Ogden, Utah, United States, 84405
Salt Lake City, Utah, United States, 84107
West Jordan, Utah, United States, 84088
United States, Virginia
Charlottesville, Virginia, United States, 22911
Chesapeake, Virginia, United States, 23320
Danville, Virginia, United States, 24541
Fairfax, Virginia, United States, 22031
Richmond, Virginia, United States, 23225
Suffolk, Virginia, United States, 23434
United States, Washington
Bellevue, Washington, United States, 98004
Seattle, Washington, United States, 98105
Spokane, Washington, United States, 99208
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53215
Milwaukee, Wisconsin, United States, 53226
Germany
Berlin, Germany, 14193
Hamburg, Germany, 22297
United Kingdom
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Salix Pharmaceuticals
Investigators
Study Director: Enoch Bortey, PhD Salix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01543178     History of Changes
Other Study ID Numbers: RFIB3053
Study First Received: February 27, 2012
Last Updated: February 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
IBS
IBS-D
IBS with diarrhea
Diarrhea
Irritable bowel syndrome with diarrhea

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rifaximin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 01, 2014