Irritable Bowel SyndromePhase 2NCT00269412
Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome
A Phase 2 study testing Rifaximin in people with Irritable Bowel Syndrome, run by Bausch Health Americas, Inc. at 67 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Rifaximin
- How many people
- 525 participants
- Where
- 67 sitesUnited States
- Study dates
- Dec 2005to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
67 sites in 1 country.
67 sites in 1 country
United States67 sites
Advanced Clinical Research Institute
Anaheim, California, 92801
Community Clinical Research Center
Anderson, Indiana, 46016
Digestive Disorders Associates
Annapolis, Maryland, 21401
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801
Austin Gastroenterology
Austin, Texas, 78745
Northwest Gastroenterology Associates
Bellevue, Washington, 98004
Coastal Research Associates
Braintree, Massachusetts, 02184
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, 06606
Connecticut Gastroenterology Institute
Bristol, Connecticut, 06010-0977
University of North Carolina
Chapel Hill, North Carolina, 27579
Charlotte Gastroenterology & Hepatology
Charlotte, North Carolina, 28207
ClinSearch
Chattanooga, Tennessee, 37404
Henry Ford Hospital
Chesterfield, Michigan, 48047
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Digestive Health Network
Cincinnati, Ohio, 45220
Clinical Research of West Florida
Clearwater, Florida, 33765
Columbia Gastroenterology Associates
Columbia, South Carolina, 29203
Internal Medicine Associates
Danville, Virginia, 24541
Gastrointestinal Clinic of Quad Citites
Davenport, Iowa, 52807
GI & Liver Diseases Consultants
Dayton, Ohio, 45440
University Clinical Research
DeLand, Florida, 32720
Long Island Clinical Research
Great Neck, New York, 11021
Vital re:Search
Greensboro, North Carolina, 27408
Carolina Research
Greenville, North Carolina, 27834
Washington County Hospital
Hagerstown, Maryland, 21740
Research Consultants Group
Hialeah, Florida, 33016
Bethany Medical Center
High Point, North Carolina, 27262
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237
Lovelace Scientific Resources
Irvine, California, 92618
Gastrointestinal Associates, PA
Jackson, Mississippi, 39202
Regional Research Institute
Jackson, Tennessee, 38305
Borland-Groover Clinic
Jacksonville, Florida, 32256
East Carolina Gastroenterology
Jacksonville, North Carolina, 28546
University of Kansas Medical Center
Kansas City, Kansas, 66160-7350
Gastroenterology and Hepatology
Kansas City, Missouri, 64131
Wells Institute for Health Awareness
Kettering, Ohio, 45429
Holston Valley Physicians
Kingsport, Tennessee, 37660
New York Center for Clinical Research
Lake Success, New York, 11042
Gastroenterology Specialities
Lincoln, Nebraska, 68503
West Gastroenterology Medical Group
Los Angeles, California, 90045
Beverly Hills Gastroenterology
Los Angeles, California, 90067
Center for Digestive & Liver Diseases, Inc.
Mexico, Missouri, 65265
Miami Research Associates
Miami, Florida, 33173
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215
Advanced Research Institute
Ogden, Utah, 84405
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104
Digestive Health Specialists, PA
Oklahoma City, Oklahoma, 73112
Advanced Gastroenterology Associates
Palm Harbor, Florida, 34684
West Hills Gastroenterology Associates, PC
Portland, Oregon, 97225
Wake Research Associates
Raleigh, North Carolina, 27612
North Pacific Clinical Research
Redmond, Washington, 98052
Rockford Gastroenterology
Rockford, Illinois, 61107
Study site
Rocky Mount, North Carolina, 27804
University of Utah School of Medicine
Salt Lake City, Utah, 84132
Medical Associates Research Group
San Diego, California, 92123
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
Maryland Clinical Trials
Severna Park, Maryland, 21146
Capital Gastroenterology Consultants, PA
Silver Springs, Maryland, 20901
Spokane Digestive Disease Center
Spokane, Washington, 99204
Specialist in Gastroenterology
St Louis, Missouri, 63141
Premeire Pharmaceutical Research
Tempe, Arizona, 85282
Litchfield County Gastroenterology Associates, LLC
Torrington, Connecticut, 06790
Digestive Health Specialists, PA
Tupelo, Mississippi, 38801
Hanover Medical Specialists, PA
Wilmington, North Carolina, 28401
Shafran Gastroenterology
Winter Park, Florida, 32789
Florida Medical Clinic
Zephyrhills, Florida, 33542
About this study
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
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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Rifaximin
- Keywords
- Irritable bowel syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (3)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionAug 2007
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 525 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269412
- Sponsor's protocol ID
- RFIB2001
- Status last verified
- Nov 2019
- First submitted
- 22 Dec 2005
- Last updated
- 25 Nov 2019
- Results posted
- No
Publications
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.
PubMed 24697851
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00269412
- Acronym / sponsor ID
- RFIB2001
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 525 participants (estimated)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 23 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifaximin | Drug | – |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Derived from this study: PubMed 24697851Schoenfeld 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
67 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rifaximin in people with Irritable Bowel Syndrome, run by Bausch Health Americas, Inc. at 67 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00269412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.