Trial · NCT00724126

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

NCT00724126, Phase 3, Completed, Bausch Health Americas, Inc.; results first posted 2014-07-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS). Trials, record NCT00724126. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00724126

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)
NCT number: NCT00724126
Status: Completed
Phases: Phase 3
Enrollment: 637 participants, actual
Lead sponsor: Bausch Health Americas, Inc.
Conditions: Non-Constipation Irritable Bowel Syndrome
Interventions: Rifaximin, Placebo
First posted: 2008-07-29
Last updated: 2019-11-29
Results first posted: 2014-07-28

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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).	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? \[Yes/No\]"
Secondary	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)	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? \[Yes/No\]."

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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).	4 weeks	The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug. Two randomized subjects (1 in each group) did not receive study drug and were not included in the intent-to-treat population.	percentage of responders	NUMBER
SECONDARY	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)	4 weeks	The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug. Two randomized subjects (1 in each group) did not receive study drug and were not included in the intent-to-treat population.	percentage of responders	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
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).	Placebo	32.2	percentage of responders
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).	Rifaximin	40.6	percentage of responders
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)	Placebo	31.9	percentage of responders
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)	Rifaximin	41.0	percentage of responders

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	321
Overall Study	STARTED	Rifaximin	316
Overall Study	COMPLETED	Placebo	302
Overall Study	COMPLETED	Rifaximin	301
Overall Study	NOT COMPLETED	Placebo	19
Overall Study	NOT COMPLETED	Rifaximin	15

Source ClinicalTrials.gov

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain	Gastrointestinal disorders	Placebo	11	320
other	Abdominal pain	Gastrointestinal disorders	Rifaximin	10	315
other	Constipation	Gastrointestinal disorders	Placebo	8	320
other	Constipation	Gastrointestinal disorders	Rifaximin	1	315
other	Diarrhoea	Gastrointestinal disorders	Placebo	7	320
other	Diarrhoea	Gastrointestinal disorders	Rifaximin	13	315
other	Nausea	Gastrointestinal disorders	Placebo	11	320
other	Nausea	Gastrointestinal disorders	Rifaximin	5	315
other	Bronchitis	Infections and infestations	Placebo	9	320
other	Bronchitis	Infections and infestations	Rifaximin	7	315

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Rifaximin
Total, other adverse events	Placebo	94	320
Total, other adverse events	Rifaximin	86	315
Total, serious adverse events	Placebo	7	320
Total, serious adverse events	Rifaximin	7	315

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21208106	RESULT	PubMed
24697851	DERIVED	PubMed
36922331	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Rifaximin vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00724126

GET https://conductscience.org/api/trials/v1/NCT00724126/events?page=2

API reference For AI assistants