Trial · NCT01543178
Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study
NCT01543178, Phase 3, Completed, Bausch Health Americas, Inc.; results first posted 2015-07-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study. Trials, record NCT01543178. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01543178
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study
- NCT number
- NCT01543178
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,583 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Interventions
- open-label rifaximin, double-blind placebo, double-blind rifaximin
- First posted
- 2012-03-02
- Last updated
- 2017-12-12
- Results first posted
- 2015-07-08
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Repeat Treatment Responders | 4-week treatment-free follow-up in double-blind repeat treatment phase. | Subjects who respond to repeat treatment in both IBS-related abdominal pain and stool consistency. The proportion of patients who responded to repeat treatment during the first double-blind repeat treatment phase is presented. Response is defined as improvement from baseline in abdominal pain AND reduction from baseline in diarrhea. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Repeat Treatment Responders | 4-week treatment-free follow-up in double-blind repeat treatment phase. | Intent-to-treat population, defined as patients who received ≥ 1 dose of study drug in the double-blind period. | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Repeat Treatment Responders | Double-blind Rifaximin (Retreatment) | 32.6 | percentage of patients | ||
| Repeat Treatment Responders | Double-blind Placebo (Retreatment) | 25.0 | percentage of patients |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-label Period | STARTED | Open-label Rifaximin | 2,583 | |
| Open-label Period | STARTED | Double-blind Rifaximin (Retreatment) | 0 | |
| Open-label Period | STARTED | Double-blind Placebo (Retreatment) | 0 | |
| Open-label Period | COMPLETED | Open-label Rifaximin | 636 | |
| Open-label Period | COMPLETED | Double-blind Rifaximin (Retreatment) | 0 | |
| Open-label Period | COMPLETED | Double-blind Placebo (Retreatment) | 0 | |
| Open-label Period | NOT COMPLETED | Open-label Rifaximin | 1,947 | |
| Open-label Period | NOT COMPLETED | Double-blind Rifaximin (Retreatment) | 0 | |
| Open-label Period | NOT COMPLETED | Double-blind Placebo (Retreatment) | 0 | |
| Double-blind Period | STARTED | Open-label Rifaximin | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events144
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 | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Total Open-label Experience | 20 | 2,579 | |
| other | Diarrhoea | Gastrointestinal disorders | Double-blind Retreatment Experience - Rifaximin Group | 7 | 328 | |
| other | Diarrhoea | Gastrointestinal disorders | Double-blind Retreatment Experience - Placebo Group | 3 | 308 | |
| other | Nausea | Gastrointestinal disorders | Total Open-label Experience | 52 | 2,579 | |
| other | Nausea | Gastrointestinal disorders | Double-blind Retreatment Experience - Rifaximin Group | 12 | 328 | |
| other | Nausea | Gastrointestinal disorders | Double-blind Retreatment Experience - Placebo Group | 7 | 308 | |
| other | Vomiting | Gastrointestinal disorders | Total Open-label Experience | 24 | 2,579 | |
| other | Vomiting | Gastrointestinal disorders | Double-blind Retreatment Experience - Rifaximin Group | 2 | 328 | |
| other | Vomiting | Gastrointestinal disorders | Double-blind Retreatment Experience - Placebo Group | 5 | 308 | |
| other | Bronchitis | Infections and infestations | Total Open-label Experience | 15 | 2,579 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total Open-label Experience | ||
| Total, all-cause mortality | Double-blind Retreatment Experience - Rifaximin Group | ||
| Total, all-cause mortality | Double-blind Retreatment Experience - Placebo Group | ||
| Total, other adverse events | Total Open-label Experience | 198 | 2,579 |
| Total, other adverse events | Double-blind Retreatment Experience - Rifaximin Group | 74 | 328 |
| Total, other adverse events | Double-blind Retreatment Experience - Placebo Group | 69 | 308 |
| Total, serious adverse events | Total Open-label Experience | 28 | 2,579 |
| Total, serious adverse events | Double-blind Retreatment Experience - Rifaximin Group | 4 | 328 |
| Total, serious adverse events | Double-blind Retreatment Experience - Placebo Group | 4 | 308 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT01543178
GET https://conductscience.org/api/trials/v1/NCT01543178/events?page=2