Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS) (TARGET 1)

November 26, 2019 updated by: Bausch Health Americas, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

623

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1E 2E2
    • Ontario
      • Corunna, Ontario, Canada, N0N 1G0
      • Hamilton, Ontario, Canada, L8N 3Z5
      • Hamilton, Ontario, Canada, L8M 1K7
      • Hamilton, Ontario, Canada, L9N 4A6
      • London, Ontario, Canada, N6A 5R8
      • London, Ontario, Canada, N6A 5R9
      • Newmarket, Ontario, Canada, L3Y 5G8
      • Niagara Falls, Ontario, Canada, L2G 1J4
      • Sarnia, Ontario, Canada, N7T 4X3
  • United States
    • Alabama
      • Hueytown, Alabama, United States, 35023
    • Arizona
      • Phoenix, Arizona, United States, 85050
      • Sierra Vista, Arizona, United States, 85635
      • Tucson, Arizona, United States, 85741
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
      • Little Rock, Arkansas, United States, 72204
      • Sherwood, Arkansas, United States, 72120
    • California
      • Anaheim, California, United States, 92801
      • Lancaster, California, United States, 93534
      • Los Angeles, California, United States, 90045
      • Murrieta, California, United States, 92562
      • San Diego, California, United States, 92108
    • Colorado
      • Lakewood, Colorado, United States, 80215
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
      • Torrington, Connecticut, United States, 06790
    • Florida
      • Altamonte Springs, Florida, United States, 32701
      • Boynton Beach, Florida, United States, 33426
      • Gainesville, Florida, United States, 32607
      • Hollywood, Florida, United States, 33021
      • Jupiter, Florida, United States, 33458
      • Lauderdale Lakes, Florida, United States, 33319
      • Maitland, Florida, United States, 32751
      • Naples, Florida, United States, 34102
      • New Port Richey, Florida, United States, 34652
      • Orlando, Florida, United States, 32806
      • West Palm Beach, Florida, United States, 33409
      • Winter Garden, Florida, United States, 34787
      • Winter Park, Florida, United States, 32708
    • Kansas
      • Topeka, Kansas, United States, 66606
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
    • Maryland
      • Baltimore, Maryland, United States, 21215
      • Hagerstown, Maryland, United States, 21742
      • Silver Spring, Maryland, United States, 20901
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Michigan
      • Detroit, Michigan, United States, 48235
      • Kalamazoo, Michigan, United States, 49008
      • Paw Paw, Michigan, United States, 49079
    • Mississippi
      • Jackson, Mississippi, United States, 39202
    • Missouri
      • Saint Louis, Missouri, United States, 63141
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
    • New Jersey
      • Elizabeth, New Jersey, United States, 07202
      • Lumberton, New Jersey, United States, 08048
    • New York
      • Bayside, New York, United States, 11358
      • Brooklyn, New York, United States, 11214
      • New York, New York, United States, 10021
      • Troy, New York, United States, 12180
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
      • Charlotte, North Carolina, United States, 28207
      • Durham, North Carolina, United States, 27713
      • Fayetteville, North Carolina, United States, 28304
      • Greensboro, North Carolina, United States, 27408
      • High Point, North Carolina, United States, 27262
      • Mooresville, North Carolina, United States, 28117
      • Raleigh, North Carolina, United States, 27609
      • Salisbury, North Carolina, United States, 28144
      • Wilmington, North Carolina, United States, 28401
    • North Dakota
      • Fargo, North Dakota, United States, 58103
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44122
      • Columbus, Ohio, United States, 43215
      • Dayton, Ohio, United States, 45440
      • Zanesville, Ohio, United States, 43701
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
    • Oregon
      • Portland, Oregon, United States, 97210
      • Portland, Oregon, United States, 97225
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
    • Tennessee
      • Germantown, Tennessee, United States, 38138
      • Jackson, Tennessee, United States, 38301
      • Johnson City, Tennessee, United States, 37604
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Austin, Texas, United States, 78705
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77074
      • Houston, Texas, United States, 77090
      • Pasadena, Texas, United States, 77504
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78258
      • San Antonio, Texas, United States, 78215
      • Tyler, Texas, United States, 75701
    • Utah
      • Ogden, Utah, United States, 84405
      • West Jordan, Utah, United States, 84088
    • Virginia
      • Chesapeake, Virginia, United States, 23320
      • Lynchburg, Virginia, United States, 24502
    • Washington
      • Bellevue, Washington, United States, 98004
      • Spokane, Washington, United States, 99216
    • Wisconsin
      • West Bend, Wisconsin, United States, 53095

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Drug: Placebo
Experimental: Rifaximin
Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Drug: Rifaximin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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]"
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 4 weeks
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]."
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Investigators

  • Study Director: Enoch Bortey, Bausch Health Americas, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

July 16, 2008

First Submitted That Met QC Criteria

August 8, 2008

First Posted (Estimate)

August 11, 2008

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RFIB3007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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