AzTrials
AzTrials

Irritable Bowel Syndrome With DiarrheaPhase 3TARGET3NCT01543178

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

A Phase 3 study testing open-label rifaximin and double-blind rifaximin in people with Irritable Bowel Syndrome With Diarrhea, run by Bausch Health Americas, Inc. at 296 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Irritable Bowel Syndrome With Diarrhea
What is being tested?
open-label rifaximin and double-blind rifaximin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,583 participants
Where
296 sitesin 3 countries
Study dates
Feb 2012to Jun 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

296 sites in 3 countries.

296 sites in 3 countries

United States293 sites

  • Study site

    Akron, Ohio, 44302

  • Study site

    Akron, Ohio, 44311

  • Study site

    Albuquerque, New Mexico, 87102

  • Study site

    Albuquerque, New Mexico, 87108

  • Study site

    Anaheim, California, 92801

  • Study site

    Ann Arbor, Michigan, 48109

  • Study site

    Annapolis, Maryland, 21401

  • Study site

    Anniston, Alabama, 36207

  • Study site

    Arlington, Texas, 76012

  • Study site

    Arlington Heights, Illinois, 60005

  • Study site

    Artesia, California, 90701

  • Study site

    Asheboro, North Carolina, 27203

  • Study site

    Asheville, North Carolina, 28801

  • Study site

    Athens, Georgia, 30606

  • Study site

    Atlanta, Georgia, 30338

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Augusta, Georgia, 30909

  • Study site

    Augusta, Georgia, 30912

  • Study site

    Austin, Texas, 78705

  • Study site

    Austin, Texas, 78731

  • Study site

    Austin, Texas, 78735

  • Study site

    Austin, Texas, 78745

  • Study site

    Baltimore, Maryland, 21215

  • Study site

    Baltimore, Maryland, 21229

  • Study site

    Bellevue, Nebraska, 68005

  • Study site

    Bellevue, Washington, 98004

  • Study site

    Birmingham, Alabama, 35216

  • Study site

    Birmingham, Alabama, 35235

  • Study site

    Birmingham, Alabama, 35243

  • Study site

    Birmingham, Alabama, 35405

  • Study site

    Boca Raton, Florida, 33428

  • Study site

    Boca Raton, Florida, 33432

  • Study site

    Boise, Idaho, 83642

  • Study site

    Boise, Idaho, 83709

  • Study site

    Boone, North Carolina, 28607

  • Study site

    Boston, Massachusetts, 02135

  • Study site

    Bountiful, Utah, 84010

  • Study site

    Bowling Green, Kentucky, 42101

  • Study site

    Boynton Beach, Florida, 33426

  • Study site

    Boynton Beach, Florida, 33472

  • Study site

    Brandon, Florida, 33511

  • Study site

    Brentwood, Tennessee, 37027

  • Study site

    Bridgeport, Connecticut, 06606

  • Study site

    Bristol, Connecticut, 06010

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Brockton, Massachusetts, 02302

  • Study site

    Brooklyn, New York, 11206

  • Study site

    Carlsbad, California, 92008

  • Study site

    Cary, North Carolina, 27518

  • Study site

    Centerville, Ohio, 45459

  • Study site

    Chandler, Arizona, 85224

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Charleston, South Carolina, 29407

  • Study site

    Charleston, South Carolina, 29412

  • Study site

    Charlotte, North Carolina, 28207

  • Study site

    Charlottesville, Virginia, 22911

  • Study site

    Chattanooga, Tennessee, 37421

  • Study site

    Chesapeake, Virginia, 23320

  • Study site

    Chicago, Illinois, 60602

  • Study site

    Chula Vista, California, 91910

  • Study site

    Chula Vista, California, 91911

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Clearwater, Florida, 33756

  • Study site

    Cleveland, Ohio, 44115

  • Study site

    Clive, Iowa, 50325

  • Study site

    Colorado Springs, Colorado, 80920

  • Study site

    Colorado Springs, Colorado, 90807

  • Study site

    Columbia, South Carolina, 29203

  • Study site

    Columbus, Georgia, 31904

  • Study site

    Columbus, Georgia, 31909

  • Study site

    Columbus, Ohio, 43214

  • Study site

    Columbus, Ohio, 43215

  • Study site

    Concord, California, 94520

  • Study site

    Corsicana, Texas, 75110

  • Study site

    Crestview Hills, Kentucky, 41017

  • Study site

    Dallas, Texas, 75224

  • Study site

    Danbury, Connecticut, 06810

  • Study site

    Danville, Virginia, 24541

  • Study site

    Dayton, Ohio, 45415

  • Study site

    Dayton, Ohio, 45432

  • Study site

    Denver, Colorado, 80211

  • Study site

    Denver, Colorado, 80220

  • Study site

    Dothan, Alabama, 36305

  • Study site

    Downingtown, Pennsylvania, 19335

  • Study site

    East Providence, Rhode Island, 02914

  • Study site

    El Paso, Texas, 79905

  • Study site

    Elkhart, Indiana, 46514

  • Study site

    Encinitas, California, 92024

  • Study site

    Encino, California, 91436

  • Study site

    Escondido, California, 92025

  • Study site

    Evanston, Illinois, 60201

  • Study site

    Evansville, Indiana, 47713

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Fairfax, Virginia, 22031

  • Study site

    Fargo, North Dakota, 85103

  • Study site

    Fort Mill, South Carolina, 29707

  • Study site

    Franklin, Tennessee, 37067

  • Study site

    Fremont, Nebraska, 68025

  • Study site

    Gaffney, South Carolina, 29341

  • Study site

    Gainesville, Florida, 32607

  • Study site

    Garden Grove, California, 92840

  • Study site

    Garden Grove, California, 92844

  • Study site

    Garden Grove, California, 92845

  • Study site

    Germantown, Tennessee, 38138

  • Study site

    Glendale, California, 91204

  • Study site

    Great Neck, New York, 11021

  • Study site

    Great Neck, New York, 11023

  • Study site

    Greensboro, North Carolina, 27403

  • Study site

    Greensboro, North Carolina, 27408

  • Study site

    Greer, South Carolina, 29650

  • Study site

    Groveport, Ohio, 43215

  • Study site

    Haddon Heights, New Jersey, 08030

  • Study site

    Hagerstown, Maryland, 21742

  • Study site

    Hayden Lake, Idaho, 83835

  • Study site

    Hebron, Kentucky, 41048

  • Study site

    Henderson, Nevada, 89052

  • Study site

    Hermitage, Tennessee, 37076

  • Study site

    Hialeah, Florida, 33010

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Hialeah, Florida, 33016

  • Study site

    High Point, North Carolina, 27262

  • Study site

    Hollis, New York, 11423

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Hollywood, Maryland, 20636

  • Study site

    Houston, Texas, 77005

  • Study site

    Houston, Texas, 77011

  • Study site

    Houston, Texas, 77030

  • Study site

    Houston, Texas, 77074

  • Study site

    Houston, Texas, 77090

  • Study site

    Houston, Texas, 77098

  • Study site

    Huntington Beach, California, 92647

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Idaho Falls, Idaho, 83406

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Jackson, Mississippi, 39202

  • Study site

    Jonesboro, Arkansas, 82401

  • Study site

    Jupiter, Florida, 33458

  • Study site

    Kalamazoo, Michigan, 49008

  • Study site

    Kalamazoo, Michigan, 49009

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Kansas City, Missouri, 64114

  • Study site

    Kettering, Ohio, 45429

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    Kinston, North Carolina, 28501

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    La Mesa, California, 91942

  • Study site

    La Mirada, California, 90638

  • Study site

    Laguna Hills, California, 92653

  • Study site

    Lake Jackson, Texas, 77566

  • Study site

    Lake Worth, Florida, 33449

  • Study site

    Lakewood, California, 90712

  • Study site

    Lakewood, Colorado, 80215

  • Study site

    Largo, Florida, 33777

  • Study site

    Las Vegas, Nevada, 89109

  • Study site

    Las Vegas, Nevada, 89128

  • Study site

    Lauderdale Lakes, Florida, 33319

  • Study site

    Lebanon, New Hampshire, 05756

  • Study site

    Lee's Summit, Missouri, 64064

  • Study site

    Lexington, Kentucky, 40504

  • Study site

    Lexington, Kentucky, 40509

  • Study site

    Lincoln, California, 95648

  • Study site

    Little Rock, Arkansas, 72204

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Little Rock, Arkansas, 72212

  • Study site

    Lomita, California, 90717

  • Study site

    Lone Tree, Colorado, 80124

  • Study site

    Long Beach, California, 90806

  • Study site

    Long Beach, California, 90813

  • Study site

    Los Angeles, California, 90036

  • Study site

    Los Angeles, California, 90045

  • Study site

    Los Angeles, California, 90048

  • Study site

    Louisville, Kentucky, 40291

  • Study site

    Macon, Georgia, 31201

  • Study site

    Madera, California, 93619

  • Study site

    Madisonville, Kentucky, 42431

  • Study site

    Maitland, Florida, 32751

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Marlborough, Massachusetts, 01752

  • Study site

    Marlton, New Jersey, 08053

  • Study site

    Medford, Oregon, 97504

  • Study site

    Mentor, Ohio, 44060

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Mexico, Missouri, 65265

  • Study site

    Miami, Florida, 33015

  • Study site

    Miami, Florida, 33136

  • Study site

    Miami, Florida, 33143

  • Study site

    Miami, Florida, 33144

  • Study site

    Miami, Florida, 33155

  • Study site

    Miami, Florida, 33156

  • Study site

    Miami, Florida, 33165

  • Study site

    Miami, Florida, 33174

  • Study site

    Miami Springs, Florida, 33166

  • Study site

    Mill Valley, California, 94941

  • Study site

    Milwaukee, Wisconsin, 53215

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    Mineola, New York, 39202

  • Study site

    Mishawaka, Indiana, 46545

  • Study site

    Missoula, Montana, 59808

  • Study site

    Montebello, California, 90640

  • Study site

    Montgomery, Alabama, 36104

  • Study site

    Montgomery, Alabama, 36109

  • Study site

    Naples, Florida, 34102

  • Study site

    Nashville, Tennessee, 37205

  • Study site

    New Orleans, Louisiana, 70115

  • Study site

    New York, New York, 10075

  • Study site

    Newington, New Hampshire, 03801

  • Study site

    Norcross, Georgia, 30092

  • Study site

    Norman, Oklahoma, 73069

  • Study site

    North Hollywood, California, 91606

  • Study site

    North Little Rock, Arkansas, 72117

  • Study site

    Oak Lawn, Illinois, 60453

  • Study site

    Ocean Springs, Mississippi, 39564

  • Study site

    Odessa, Texas, 79761

  • Study site

    Ogden, Utah, 84405

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Oklahoma City, Oklahoma, 73120

  • Study site

    Omaha, Nebraska, 68130

  • Study site

    Orange, California, 92868

  • Study site

    Orange Park, Florida, 32073

  • Study site

    Orlando, Florida, 32806

  • Study site

    Ormond Beach, Florida, 32174

  • Study site

    Overland Park, Kansas, 66215

  • Study site

    Pasadena, Texas, 77505

  • Study site

    Peoria, Arizona, 85381

  • Study site

    Phoenix, Arizona, 85018

  • Study site

    Pittsburgh, Pennsylvania, 15206

  • Study site

    Plano, Texas, 75075

  • Study site

    Plant City, Florida, 33563

  • Study site

    Pompano Beach, Florida, 33060

  • Study site

    Port Orange, Florida, 32127

  • Study site

    Portland, Oregon, 97210

  • Study site

    Poughkeepsie, New York, 12601

  • Study site

    Raleigh, North Carolina, 27613

  • Study site

    Reading, Pennsylvania, 19606

  • Study site

    Redlands, California, 92374

  • Study site

    Reno, Nevada, 89511

  • Study site

    Richmond, Virginia, 23225

  • Study site

    Rochester, New York, 14609

  • Study site

    Sacramento, California, 95821

  • Study site

    Saginaw, Michigan, 48604

  • Study site

    Salisbury, North Carolina, 28144

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Antonio, Texas, 78215

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Antonio, Texas, 78258

  • Study site

    San Carlos, California, 94070

  • Study site

    San Diego, California, 92101

  • Study site

    San Diego, California, 92108

  • Study site

    San Diego, California, 92114

  • Study site

    San Diego, California, 92123

  • Study site

    Sarasota, Florida, 34231

  • Study site

    Sayre, Pennsylvania, 18840

  • Study site

    Scottsdale, Arizona, 85257

  • Study site

    Sealy, Texas, 77474

  • Study site

    Seattle, Washington, 98105

  • Study site

    Selma, Alabama, 37601

  • Study site

    Seminole, Florida, 33777

  • Study site

    Sherwood, Arkansas, 72120

  • Study site

    Shreveport, Louisiana, 71103

  • Study site

    Southlake, Texas, 76092

  • Study site

    Spokane, Washington, 99208

  • Study site

    St Louis, Missouri, 63104

  • Study site

    St Louis, Missouri, 63122

  • Study site

    St Louis, Missouri, 63141

  • Study site

    St. Petersburg, Florida, 33709

  • Study site

    Suffolk, Virginia, 23434

  • Study site

    Tampa, Florida, 33603

  • Study site

    Tampa, Florida, 33613

  • Study site

    Tempe, Arizona, 85282

  • Study site

    Topeka, Kansas, 66604

  • Study site

    Torrington, Connecticut, 06790

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Tucson, Arizona, 85710

  • Study site

    Tucson, Arizona, 85712

  • Study site

    Tulsa, Oklahoma, 74104

  • Study site

    Tulsa, Oklahoma, 74136

  • Study site

    Tyler, Texas, 75701

  • Study site

    Vista, California, 92083

  • Study site

    Warwick, Rhode Island, 02886

  • Study site

    Watertown, Massachusetts, 02472

  • Study site

    Wellington, Florida, 33414

  • Study site

    West Jordan, Utah, 84088

  • Study site

    West Palm Beach, Florida, 33406

  • Study site

    West Palm Beach, Florida, 33409

  • Study site

    Wichita, Kansas, 67226

  • Study site

    Wilmington, North Carolina, 28479

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Winter Haven, Florida, 33880

  • Study site

    Winter Park, Florida, 32789

  • Study site

    Wyoming, Michigan, 49519

  • Study site

    Zephyrhills, Florida, 33542

Other trials in United States

Germany2 sites

  • Study site

    Berlin, 14193

  • Study site

    Hamburg, 22297

Other trials in Germany

United Kingdom1 site

  • Study site

    Manchester, M23 9LT

Other trials in United Kingdom

About this study

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)

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.

Read the 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.

Being tested
open-label rifaximin, double-blind placebo, double-blind rifaximin
Keywords
IBS, IBS-D, IBS with diarrhea, Diarrhea, Irritable bowel syndrome with diarrhea
Medical subject headings
Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • open-label rifaximinDrug

    Also called rifaximin

    550 mg three times a day (open-label)

  • double-blind placeboDrug

    Also called Placebo

    3 times a day (double-blind)

  • double-blind rifaximinDrug

    Also called rifaximin

    550 mg three times a day (double-blind)

Study groups in NCT01543178
Study groupRoleWhat they receive
Rifaximin open-labelExperimentalSubjects 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.
Receives: Drug: open-label rifaximin
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.
Receives: Drug: open-label rifaximin; Drug: double-blind rifaximin
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.
Receives: Drug: open-label rifaximin; Drug: double-blind placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4-week treatment-free follow-up in double-blind repeat treatment phase.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,583 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01543178
Sponsor's protocol ID
RFIB3053
Acronym
TARGET3
Status last verified
Dec 2017
First submitted
27 Feb 2012
Last updated
12 Dec 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 36922331

  • 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.

    PubMed 29708822

  • 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. Ther Adv Gastroenterol. 2017 Sep;10(9):689-699. doi: 10.1177/1756283X17726087. Epub 2017 Sep 11.

    PubMed 28932270

  • 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.

    PubMed 28589238

  • 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.

    PubMed 27795384

  • 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.

    PubMed 27528177

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing open-label rifaximin and double-blind rifaximin in people with Irritable Bowel Syndrome With Diarrhea, run by Bausch Health Americas, Inc. at 296 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 296 sites in United States, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Repeat Treatment Responders (time frame: 4-week treatment-free follow-up in double-blind repeat treatment phase.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01543178, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.

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