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Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS) (TARGET 2)

Primary Purpose

Non-Constipation Irritable Bowel Syndrome

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rifaximin
Placebo
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Constipation Irritable Bowel Syndrome focused on measuring Diarrhea, Rifaximin, IBS, Abdominal pain, Bloating

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed IBS diagnosis per Rome II criteria 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Rifaximin

Arm Description

Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.

Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.

Outcomes

Primary Outcome Measures

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]"

Secondary Outcome Measures

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]."

Full Information

First Posted
July 26, 2008
Last Updated
November 26, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00724126
Brief Title
Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)
Acronym
TARGET 2
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Constipation Irritable Bowel Syndrome
Keywords
Diarrhea, Rifaximin, IBS, Abdominal pain, Bloating

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
637 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Arm Title
Rifaximin
Arm Type
Experimental
Arm Description
Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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).
Description
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]"
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
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)
Description
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]."
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed IBS diagnosis per Rome II criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enoch Bortey
Organizational Affiliation
Bausch Health Americas, Inc.
Official's Role
Study Director
Facility Information:
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
City
San Carlos
State/Province
California
ZIP/Postal Code
94070
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
City
Largo
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42104
Country
United States
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
City
Wellesley
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
City
Sicklerville
State/Province
New Jersey
ZIP/Postal Code
08081
Country
United States
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
City
Pomona
State/Province
New York
ZIP/Postal Code
10970
Country
United States
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
City
Boone
State/Province
North Carolina
ZIP/Postal Code
28607
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
City
Downingtown
State/Province
Pennsylvania
ZIP/Postal Code
19335
Country
United States
City
Newtown
State/Province
Pennsylvania
ZIP/Postal Code
18940
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75057
Country
United States
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21208106
Citation
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.
Results Reference
result
PubMed Identifier
24697851
Citation
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.
Results Reference
derived

Learn more about this trial

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

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