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Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rifaximin
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable bowel syndrome

Eligibility Criteria

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

Inclusion Criteria: Male or female subject 18 years of age or older. Irritable bowel syndrome confirmed by the Rome II Criteria Lower endoscopic examination that demonstrates normal colonic anatomy Exclusion Criteria: Subject has exclusively constipation-predominant IBS (CIBS) that is characterized by < 3 bowel movements/week or hard and lumpy stools. Subject has alternating IBS, but is currently presenting with constipation associated IBS symptoms. Subject has had adequate control of their DIBS and their symptom of bloating the week preceding the screening visit or at the time of randomization. Bloating includes the following symptoms: abdominal fullness, bloating, gas, or swelling. Subjects has a positive stool culture for O & P (ovum and parasite) and/or Clostridium difficile Subject has failed to record 2 negative weekly global assessments during the past 10 days prior to randomization.

Sites / Locations

  • Mayo Clinic Scottsdale
  • Premeire Pharmaceutical Research
  • Advanced Clinical Research Institute
  • Lovelace Scientific Resources
  • West Gastroenterology Medical Group
  • Beverly Hills Gastroenterology
  • Medical Associates Research Group
  • Gastroenterology Associates of Fairfield County
  • Connecticut Gastroenterology Institute
  • Litchfield County Gastroenterology Associates, LLC
  • Clinical Research of West Florida
  • University Clinical Research
  • Research Consultants Group
  • Borland-Groover Clinic
  • Miami Research Associates
  • Advanced Gastroenterology Associates
  • Shafran Gastroenterology
  • Florida Medical Clinic
  • Rockford Gastroenterology
  • Community Clinical Research Center
  • Indianapolis Gastroenterology Research Foundation
  • Gastrointestinal Clinic of Quad Citites
  • University of Kansas Medical Center
  • Digestive Disorders Associates
  • Chevy Chase Clinical Research
  • Washington County Hospital
  • Maryland Clinical Trials
  • Capital Gastroenterology Consultants, PA
  • Coastal Research Associates
  • Henry Ford Hospital
  • Gastrointestinal Associates, PA
  • Digestive Health Specialists, PA
  • Gastroenterology and Hepatology
  • Center for Digestive & Liver Diseases, Inc.
  • Specialist in Gastroenterology
  • Gastroenterology Specialities
  • Long Island Clinical Research
  • New York Center for Clinical Research
  • Asheville Gastroenterology Associates
  • University of North Carolina
  • Charlotte Gastroenterology & Hepatology
  • Vital re:Search
  • Carolina Research
  • Bethany Medical Center
  • East Carolina Gastroenterology
  • Wake Research Associates
  • Hanover Medical Specialists, PA
  • Consultants for Clinical Research
  • Digestive Health Network
  • GI & Liver Diseases Consultants
  • Wells Institute for Health Awareness
  • Oklahoma Foundation for Digestive Research
  • Digestive Health Specialists, PA
  • West Hills Gastroenterology Associates, PC
  • Columbia Gastroenterology Associates
  • ClinSearch
  • Regional Research Institute
  • Holston Valley Physicians
  • Austin Gastroenterology
  • Advanced Research Institute
  • University of Utah School of Medicine
  • Internal Medicine Associates
  • Northwest Gastroenterology Associates
  • North Pacific Clinical Research
  • Spokane Digestive Disease Center
  • Wisconsin Center for Advanced Research

Outcomes

Primary Outcome Measures

The primary objective of this trial is to evaluate the efficacy of a 14-day course of oral rifaximin at 550 mg BID versus placebo in providing adequate relief from Diarrhea-associated IBS (DIBS) symptoms.

Secondary Outcome Measures

To evaluate the dose-response relationship of placebo administered for 28 days and rifaximin administered at 275 mg BID, 550 mg BID, or 1100 mg BID for 14 days;
to evaluate the efficacy of 550 mg BID for 4 weeks to determine if there are any differences when treatment is extended for an additional 2-week period when compared to a similar dosing regimen for 2 weeks;
to evaluate the durability of response over a 12-week Post-treatment Phase in subjects with DIBS who achieved a response during the acute Treatment Phase of the study.

Full Information

First Posted
December 22, 2005
Last Updated
November 21, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00269412
Brief Title
Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome
Official Title
Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess The Efficacy and Safety of Three Different Doses (275, 550 AND 1100 MG) of Rifaximin Administered BID For Either Two or Four Weeks in The Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

5. Study Description

Brief Summary
This is placebo-controlled study of three rifaximin doses in patients with DIBS. Subjects will be randomized to receive daily doses of placebo BID, rifaximin 275 mg BID, rifaximin 550 mg BID, or 1100 mg BID for 14 days. These four groups will subsequently receive an additional two weeks of placebo for a total of 4 weeks of treatment. A fifth group of subjects will receive rifaximin 550 mg BID for a period of 28 days. Subjects who successfully respond to treatment at the end of the 28-day Treatment Phase will be followed in a Post-treatment Phase that includes study visits during Weeks 6, 8, 12 and 16. Subjects who relapse during the Post-treatment Phase will be discontinued from the study.
Detailed Description
While IBS is one of the most common chronic medical conditions the etiology of IBS is unknown. Although not a life-threatening illness, IBS is considered to be a serious condition that has a substantial impact on a subject's day-to-day function. IBS is characterized by abdominal pain and altered bowel habits, including diarrhea, constipation, or alternating diarrhea and constipation. Symptoms are typically intermittent but may be continuous.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable bowel syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
525 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rifaximin
Primary Outcome Measure Information:
Title
The primary objective of this trial is to evaluate the efficacy of a 14-day course of oral rifaximin at 550 mg BID versus placebo in providing adequate relief from Diarrhea-associated IBS (DIBS) symptoms.
Secondary Outcome Measure Information:
Title
To evaluate the dose-response relationship of placebo administered for 28 days and rifaximin administered at 275 mg BID, 550 mg BID, or 1100 mg BID for 14 days;
Title
to evaluate the efficacy of 550 mg BID for 4 weeks to determine if there are any differences when treatment is extended for an additional 2-week period when compared to a similar dosing regimen for 2 weeks;
Title
to evaluate the durability of response over a 12-week Post-treatment Phase in subjects with DIBS who achieved a response during the acute Treatment Phase of the study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subject 18 years of age or older. Irritable bowel syndrome confirmed by the Rome II Criteria Lower endoscopic examination that demonstrates normal colonic anatomy Exclusion Criteria: Subject has exclusively constipation-predominant IBS (CIBS) that is characterized by < 3 bowel movements/week or hard and lumpy stools. Subject has alternating IBS, but is currently presenting with constipation associated IBS symptoms. Subject has had adequate control of their DIBS and their symptom of bloating the week preceding the screening visit or at the time of randomization. Bloating includes the following symptoms: abdominal fullness, bloating, gas, or swelling. Subjects has a positive stool culture for O & P (ovum and parasite) and/or Clostridium difficile Subject has failed to record 2 negative weekly global assessments during the past 10 days prior to randomization.
Facility Information:
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Premeire Pharmaceutical Research
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Lovelace Scientific Resources
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
West Gastroenterology Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Beverly Hills Gastroenterology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Facility Name
Medical Associates Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Gastroenterology Associates of Fairfield County
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Connecticut Gastroenterology Institute
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010-0977
Country
United States
Facility Name
Litchfield County Gastroenterology Associates, LLC
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
University Clinical Research
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Research Consultants Group
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Borland-Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Advanced Gastroenterology Associates
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Shafran Gastroenterology
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Florida Medical Clinic
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Rockford Gastroenterology
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Community Clinical Research Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46016
Country
United States
Facility Name
Indianapolis Gastroenterology Research Foundation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Gastrointestinal Clinic of Quad Citites
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52807
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7350
Country
United States
Facility Name
Digestive Disorders Associates
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Washington County Hospital
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Maryland Clinical Trials
City
Severna Park
State/Province
Maryland
ZIP/Postal Code
21146
Country
United States
Facility Name
Capital Gastroenterology Consultants, PA
City
Silver Springs
State/Province
Maryland
ZIP/Postal Code
20901
Country
United States
Facility Name
Coastal Research Associates
City
Braintree
State/Province
Massachusetts
ZIP/Postal Code
02184
Country
United States
Facility Name
Henry Ford Hospital
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Gastrointestinal Associates, PA
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Digestive Health Specialists, PA
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Gastroenterology and Hepatology
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Center for Digestive & Liver Diseases, Inc.
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
Specialist in Gastroenterology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Gastroenterology Specialities
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68503
Country
United States
Facility Name
Long Island Clinical Research
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
New York Center for Clinical Research
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Asheville Gastroenterology Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27579
Country
United States
Facility Name
Charlotte Gastroenterology & Hepatology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Vital re:Search
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Carolina Research
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Bethany Medical Center
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
East Carolina Gastroenterology
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
Hanover Medical Specialists, PA
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Digestive Health Network
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
GI & Liver Diseases Consultants
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
Facility Name
Wells Institute for Health Awareness
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Oklahoma Foundation for Digestive Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Digestive Health Specialists, PA
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
West Hills Gastroenterology Associates, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Columbia Gastroenterology Associates
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
ClinSearch
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Regional Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Holston Valley Physicians
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Austin Gastroenterology
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Internal Medicine Associates
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Northwest Gastroenterology Associates
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
North Pacific Clinical Research
City
Redmond
State/Province
Washington
ZIP/Postal Code
98052
Country
United States
Facility Name
Spokane Digestive Disease Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Wisconsin Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Citations:
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

Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome

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