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

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: Non-Constipation Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: Rifaximin

• Study Type: Interventional
• Enrollment (Actual): 623
• Phase: Phase 3

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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).	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).	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

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

Publications and helpful links

General 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.
• 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.

Study record dates

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: Diarrhea; IBS; Abdominal pain; Bloating; Rifaximin
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Anti-Infective Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Rifaximin
• 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