Trial · NCT02920242

A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea.

NCT02920242, Phase 3, Terminated, Sandoz; results first posted 2019-03-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea. Trials, record NCT02920242. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02920242

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Trial

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

Title: A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea.
NCT number: NCT02920242
Status: Terminated
Phases: Phase 3
Enrollment: 28 participants, actual
Lead sponsor: Sandoz
Conditions: Travelers' Diarrhea
Interventions: Rifaximin (Sandoz GmbH) tablet, Rifaximin (Xifaxan), Placebo
First posted: 2016-09-30
Last updated: 2019-03-25
Results first posted: 2019-03-25

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Clinical Cure Rate	study day 5 +/- 1 day	Clinical cure was defined as either no stools or only formed stools within a 48 hour period and no fever, with or without other enteric symptoms, OR no watery stools or no more than two soft stools passed within a 24 hour period with no fever and no other enteric symptoms except for mild excess gas/flatulence.
Secondary	Time to Last Unformed Stool	within 5 study days
Secondary	Proportion of Patients With Clinical Failure	within 5 study days
Secondary	Proportion of Patients With Improvement of Diarrheal Syndrome	within 5 study days
Secondary	Number of Unformed Stools	within 5 study days
Secondary	The Presence or Absence and Severity of Signs and Symptoms of Enteric Infection	within 5 study days
Secondary	Microbiological Cure Rate	study day 5

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population
PRIMARY	Clinical Cure Rate	study day 5 +/- 1 day	The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.
SECONDARY	Time to Last Unformed Stool	within 5 study days	The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.
SECONDARY	Proportion of Patients With Clinical Failure	within 5 study days	The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.
SECONDARY	Proportion of Patients With Improvement of Diarrheal Syndrome	within 5 study days	The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.
SECONDARY	Number of Unformed Stools	within 5 study days	The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.
SECONDARY	The Presence or Absence and Severity of Signs and Symptoms of Enteric Infection	within 5 study days	The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.
SECONDARY	Microbiological Cure Rate	study day 5	The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.

Source ClinicalTrials.gov

Results by group0

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

None in this release.

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Rifaximin	13
Overall Study	STARTED	Xifaxan	11
Overall Study	STARTED	Placebo	4
Overall Study	Safety Set	Rifaximin	12
Overall Study	Safety Set	Xifaxan	11
Overall Study	Safety Set	Placebo	4
Overall Study	COMPLETED	Rifaximin	11
Overall Study	COMPLETED	Xifaxan	11
Overall Study	COMPLETED	Placebo	3
Overall Study	NOT COMPLETED	Rifaximin	2

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events18

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	Lacrimation increased	Eye disorders	Rifaximin	0	12
other	Lacrimation increased	Eye disorders	Xifaxan	1	11
other	Lacrimation increased	Eye disorders	Placebo	0	4
other	Abdominal pain upper	Gastrointestinal disorders	Rifaximin	0	12
other	Abdominal pain upper	Gastrointestinal disorders	Xifaxan	1	11
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	0	4
other	Constipation	Gastrointestinal disorders	Rifaximin	1	12
other	Constipation	Gastrointestinal disorders	Xifaxan	0	11
other	Constipation	Gastrointestinal disorders	Placebo	0	4
other	Medication error	Injury, poisoning and procedural complications	Rifaximin	0	12

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rifaximin	0	12
Total, all-cause mortality	Xifaxan	0	11
Total, all-cause mortality	Placebo	0	4
Total, other adverse events	Rifaximin	2	12
Total, other adverse events	Xifaxan	5	11
Total, other adverse events	Placebo	0	4
Total, serious adverse events	Rifaximin	0	12
Total, serious adverse events	Xifaxan	0	11
Total, serious adverse events	Placebo	0	4

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

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/NCT02920242

GET https://conductscience.org/api/trials/v1/NCT02920242/registered

API reference For AI assistants