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

Primary Purpose

Non-Constipation Irritable Bowel Syndrome

Status
Completed
Phase
Phase 3
Locations
International
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 IBS, Abdominal pain, Bloating, Diarrhea, Rifaximin

Eligibility Criteria

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

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.

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 16, 2008
Last Updated
November 26, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00731679
Brief Title
Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)
Acronym
TARGET 1
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
IBS, Abdominal pain, Bloating, Diarrhea, Rifaximin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
623 (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 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
Hueytown
State/Province
Alabama
ZIP/Postal Code
35023
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
City
Sierra Vista
State/Province
Arizona
ZIP/Postal Code
85635
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Sherwood
State/Province
Arkansas
ZIP/Postal Code
72120
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
City
Winter Garden
State/Province
Florida
ZIP/Postal Code
34787
Country
United States
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32708
Country
United States
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20901
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48235
Country
United States
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49008
Country
United States
City
Paw Paw
State/Province
Michigan
ZIP/Postal Code
49079
Country
United States
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07202
Country
United States
City
Lumberton
State/Province
New Jersey
ZIP/Postal Code
08048
Country
United States
City
Bayside
State/Province
New York
ZIP/Postal Code
11358
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11214
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
Troy
State/Province
New York
ZIP/Postal Code
12180
Country
United States
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
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
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77504
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
City
West Bend
State/Province
Wisconsin
ZIP/Postal Code
53095
Country
United States
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1E 2E2
Country
Canada
City
Corunna
State/Province
Ontario
ZIP/Postal Code
N0N 1G0
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L9N 4A6
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5R8
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5R9
Country
Canada
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2G 1J4
Country
Canada
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada

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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