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Non-Constipation Irritable Bowel SyndromePhase 3TARGET 1NCT00731679

Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)

A Phase 3 study testing Rifaximin in people with Non-Constipation Irritable Bowel Syndrome, run by Bausch Health Americas, Inc. at 96 sites in 2 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

To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of IBS symptoms. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rifaximin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
623 participants
Where
96 sitesin 2 countries
Study dates
Jul 2008to Sep 2009
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

  • Confirmed IBS diagnosis per Rome II for diagnosis of IBS.
  • Colonoscopy within 2 years as part of IBS diagnostic evaluation.
  • Has active symptoms of non-constipation IBS at baseline as measured by average daily scores for abdominal pain/discomfort, bloating, and stool consistency.

Who cannot join

  • Symptoms of constipation.
  • History of other gastrointestinal diseases.
  • Type 1 or 2 diabetes.
  • Lactose intolerance not controlled by lactose-free diet.

Trial locations and contacts

96 sites in 2 countries.

96 sites in 2 countries

United States86 sites

  • Study site

    Altamonte Springs, Florida, 32701

  • Study site

    Anaheim, California, 92801

  • Study site

    Asheboro, North Carolina, 27203

  • Study site

    Austin, Texas, 78705

  • Study site

    Baltimore, Maryland, 21215

  • Study site

    Bayside, New York, 11358

  • Study site

    Bellevue, Washington, 98004

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Boynton Beach, Florida, 33426

  • Study site

    Bridgeport, Connecticut, 06606

  • Study site

    Brooklyn, New York, 11214

  • Study site

    Charlotte, North Carolina, 28207

  • Study site

    Chesapeake, Virginia, 23320

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cleveland, Ohio, 44122

  • Study site

    Columbus, Ohio, 43215

  • Study site

    Dayton, Ohio, 45440

  • Study site

    Detroit, Michigan, 48235

  • Study site

    Durham, North Carolina, 27713

  • Study site

    Elizabeth, New Jersey, 07202

  • Study site

    Fargo, North Dakota, 58103

  • Study site

    Fayetteville, North Carolina, 28304

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Gainesville, Florida, 32607

  • Study site

    Germantown, Tennessee, 38138

  • Study site

    Greensboro, North Carolina, 27408

  • Study site

    Hagerstown, Maryland, 21742

  • Study site

    High Point, North Carolina, 27262

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Houston, Texas, 77074

  • Study site

    Houston, Texas, 77090

  • Study site

    Hueytown, Alabama, 35023

  • Study site

    Jackson, Mississippi, 39202

  • Study site

    Jackson, Tennessee, 38301

  • Study site

    Johnson City, Tennessee, 37604

  • Study site

    Jupiter, Florida, 33458

  • Study site

    Kalamazoo, Michigan, 49008

  • Study site

    Lakewood, Colorado, 80215

  • Study site

    Lancaster, California, 93534

  • Study site

    Lancaster, Pennsylvania, 17601

  • Study site

    Lauderdale Lakes, Florida, 33319

  • Study site

    Lebanon, New Hampshire, 03756

  • Study site

    Little Rock, Arkansas, 72204

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Los Angeles, California, 90045

  • Study site

    Lumberton, New Jersey, 08048

  • Study site

    Lynchburg, Virginia, 24502

  • Study site

    Maitland, Florida, 32751

  • Study site

    Mooresville, North Carolina, 28117

  • Study site

    Murrieta, California, 92562

  • Study site

    Naples, Florida, 34102

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New Port Richey, Florida, 34652

  • Study site

    New York, New York, 10021

  • Study site

    Ogden, Utah, 84405

  • Study site

    Orlando, Florida, 32806

  • Study site

    Pasadena, Texas, 77504

  • Study site

    Paw Paw, Michigan, 49079

  • Study site

    Phoenix, Arizona, 85050

  • Study site

    Portland, Oregon, 97210

  • Study site

    Portland, Oregon, 97225

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Salisbury, North Carolina, 28144

  • Study site

    San Antonio, Texas, 78215

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Antonio, Texas, 78258

  • Study site

    San Diego, California, 92108

  • Study site

    Sherwood, Arkansas, 72120

  • Study site

    Shreveport, Louisiana, 71103

  • Study site

    Sierra Vista, Arizona, 85635

  • Study site

    Silver Spring, Maryland, 20901

  • Study site

    Spokane, Washington, 99216

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Topeka, Kansas, 66606

  • Study site

    Torrington, Connecticut, 06790

  • Study site

    Troy, New York, 12180

  • Study site

    Tucson, Arizona, 85741

  • Study site

    Tulsa, Oklahoma, 74104

  • Study site

    Tyler, Texas, 75701

  • Study site

    West Bend, Wisconsin, 53095

  • Study site

    West Jordan, Utah, 84088

  • Study site

    West Palm Beach, Florida, 33409

  • Study site

    Wilmington, North Carolina, 28401

  • Study site

    Winter Garden, Florida, 34787

  • Study site

    Winter Park, Florida, 32708

  • Study site

    Zanesville, Ohio, 43701

Other trials in United States

Canada10 sites

  • Study site

    Corunna, Ontario, N0N 1G0

  • Study site

    Hamilton, Ontario, L8M 1K7

  • Study site

    Hamilton, Ontario, L8N 3Z5

  • Study site

    Hamilton, Ontario, L9N 4A6

  • Study site

    London, Ontario, N6A 5R8

  • Study site

    London, Ontario, N6A 5R9

  • Study site

    Newmarket, Ontario, L3Y 5G8

  • Study site

    Niagara Falls, Ontario, L2G 1J4

  • Study site

    Sarnia, Ontario, N7T 4X3

  • Study site

    St. John's, Newfoundland and Labrador, A1E 2E2

Other trials in Canada

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin 550 mg TID in the Treatment of Subjects With Non-Constipation Irritable Bowel Syndrome

To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of IBS symptoms.

Being tested
Rifaximin, Placebo
Keywords
IBS, Abdominal pain, Bloating, Diarrhea, Rifaximin
Medical subject headings
Abdominal Pain, Diarrhea

What participants receive

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

  • RifaximinDrug

  • PlaceboDrug

Study groups in NCT00731679
Study groupRoleWhat they receive
PlaceboPlacebo comparatorSubjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Receives: Drug: Placebo
RifaximinExperimentalSubjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Receives: Drug: Rifaximin

What is being measured

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

  1. Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).

    The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of global IBS symptoms was defined as a response of "yes" to the following question, which was asked weekly (every 7 days): "In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/No]"

    Measured: 4 weeks

Secondary outcomes (1)

  1. Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).

    The secondary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of bloating was defined as a response of "yes" to the following question, which was asked weekly (every 7 days): "In regard to your symptom of bloating, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? [Yes/No]."

    Measured: 4 weeks

Timeline

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

  1. First posted11 Aug 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionAug 2009
  4. Study completionSep 2009

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
623 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00731679
Sponsor's protocol ID
RFIB3007
Acronym
TARGET 1
Status last verified
Nov 2019
First submitted
16 Jul 2008
Last updated
29 Nov 2019
Data monitoring committee
No

Publications

  • Pimentel M, Lembo A, Chey WD, Zakko S, Ringel Y, Yu J, Mareya SM, Shaw AL, Bortey E, Forbes WP; TARGET Study Group. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011 Jan 6;364(1):22-32. doi: 10.1056/NEJMoa1004409.

    PubMed 21208106

  • 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

  • Schoenfeld P, Pimentel M, Chang L, Lembo A, Chey WD, Yu J, Paterson C, Bortey E, Forbes WP. Safety and tolerability of rifaximin for the treatment of irritable bowel syndrome without constipation: a pooled analysis of randomised, double-blind, placebo-controlled trials. Aliment Pharmacol Ther. 2014 May;39(10):1161-8. doi: 10.1111/apt.12735. Epub 2014 Apr 3.

    PubMed 24697851

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rifaximin in people with Non-Constipation Irritable Bowel Syndrome, run by Bausch Health Americas, Inc. at 96 sites in 2 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 3 inclusion and 4 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 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States, Canada. 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 28 Jul 2014). 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?

Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6). (time frame: 4 weeks). 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 NCT00731679, which also lists 3 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 29 Nov 2019.

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