Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS) (TARGET 2)
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ClinicalTrials.gov Identifier: NCT00724126 |
Recruitment Status :
Completed
First Posted : July 29, 2008
Results First Posted : July 28, 2014
Last Update Posted : November 29, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Constipation Irritable Bowel Syndrome | Drug: Rifaximin Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 637 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | July 2008 |
Actual Primary Completion Date : | August 2009 |
Actual Study Completion Date : | September 2009 |

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.
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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.
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Drug: Rifaximin |
- 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). [ Time Frame: 4 weeks ]
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]"
- 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) [ Time Frame: 4 weeks ]
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]."

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724126

Study Director: | Enoch Bortey | Bausch Health Americas, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bausch Health Americas, Inc. |
ClinicalTrials.gov Identifier: | NCT00724126 |
Other Study ID Numbers: |
RFIB3008 |
First Posted: | July 29, 2008 Key Record Dates |
Results First Posted: | July 28, 2014 |
Last Update Posted: | November 29, 2019 |
Last Verified: | November 2019 |
Diarrhea Rifaximin IBS Abdominal pain Bloating |
Irritable Bowel Syndrome Syndrome Disease Pathologic Processes Colonic Diseases, Functional Colonic Diseases Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Rifaximin Anti-Bacterial Agents Anti-Infective Agents Gastrointestinal Agents |