Trial · NCT01142089
Study to Evaluate Safety and Efficacy of Rifamycin SV Multi-Matrix System (MMX) for the Treatment of Traveler's Diarrhea (TD)
NCT01142089, Phase 3, Completed, Cosmo Technologies Ltd; results first posted 2018-04-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate Safety and Efficacy of Rifamycin SV Multi-Matrix System (MMX) for the Treatment of Traveler's Diarrhea (TD). Trials, record NCT01142089. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01142089
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Safety and Efficacy of Rifamycin SV Multi-Matrix System (MMX) for the Treatment of Traveler's Diarrhea (TD)
- NCT number
- NCT01142089
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 264 participants, actual
- Lead sponsor
- Cosmo Technologies Ltd
- Conditions
- Traveler's Diarrhea
- Interventions
- Placebo, Rifamycin SV MMX
- First posted
- 2010-06-11
- Last updated
- 2018-06-08
- Results first posted
- 2018-04-10
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Last Unformed Stool (TLUS) | 24 hours | The primary endpoint is TLUS defined as the interval in hours between the first dose of study drug and the last unformed stool passed just before the start of Clinical Cure. An unformed stool is defined as either a soft or watery stool. TLUS will be calculated for each patient in the following manner: Step 1: Identify when the patient achieves Clinical Cure. Step 2: Moving backwards from this time, identify the time of the last unformed stool. Step 3: The TLUS equals the time from the first dose of study drug to the time of the last unformed stool identified in Step 2. |
| Secondary | Clinical Cure | 24 hours | Clinical Cure is defined as either of the following: * Passage of two or fewer soft stools and no watery stools, no fever (\>100.4 ºF or 38 ºC), and no signs or symptoms of enteric infection (other than mild excess gas/flatulence) during a 24 hour interval in the 120-hr data collection period after the first dose of study drug * Passage of no stools or only formed stools and no fever during a 48-hour interval in the 120-hr data collection period after the first dose of study drug, with or without other signs or symptoms of enteric infection |
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 | Time to Last Unformed Stool (TLUS) | 24 hours | Intent To Treat (ITT). Please note that the 75th percentile was not observed during the 120-hour study period for placebo patients.~The percentile groups indicate the hour at which the appropriate percentage of the patient group had met the primary endpoint i.e. by 72 hours, 75% of Rifamycin SV MMX patients had met the endpoint. | TLUS (hours) | MEAN |
| SECONDARY | Clinical Cure | 24 hours | Intent to treat (ITT) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Last Unformed Stool (TLUS) | Placebo | 25th percentile | 37.4 | 95% Confidence Interval 8.3 to 47.8 | TLUS (hours) |
| Time to Last Unformed Stool (TLUS) | Rifamycin SV MMX | 25th percentile | 21. | 95% Confidence Interval 12.7 to 25.8 | TLUS (hours) |
| Time to Last Unformed Stool (TLUS) | Placebo | 50th percentile | 68 | 95% Confidence Interval 48.7 to NA | TLUS (hours) |
| Time to Last Unformed Stool (TLUS) | Rifamycin SV MMX | 50th percentile | 46 | 95% Confidence Interval 42.8 to 50.5 | TLUS (hours) |
| Time to Last Unformed Stool (TLUS) | Placebo | 75th percentile | NA | 95% Confidence Interval NA to NA | TLUS (hours) |
| Time to Last Unformed Stool (TLUS) | Rifamycin SV MMX | 75th percentile | 72.2 | 95% Confidence Interval 69 to 91.7 | TLUS (hours) |
| Clinical Cure | Placebo | 35 | Participants | ||
| Clinical Cure | Rifamycin SV MMX | 162 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 65 | |
| Overall Study | STARTED | Rifamycin SV MMX | 199 | |
| Overall Study | COMPLETED | Placebo | 53 | |
| Overall Study | COMPLETED | Rifamycin SV MMX | 178 | |
| Overall Study | NOT COMPLETED | Placebo | 12 | |
| Overall Study | NOT COMPLETED | Rifamycin SV MMX | 21 |
Source ClinicalTrials.gov
Adverse events84
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 | Amoebic dysentery | Infections and infestations | Placebo | 2 | 65 | 2 |
| other | Amoebic dysentery | Infections and infestations | Rifamycin SV MMX | 0 | 199 | 0 |
| other | Neuroblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo | 0 | 65 | 0 |
| other | Neuroblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Rifamycin SV MMX | 1 | 199 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 1 | 65 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Rifamycin SV MMX | 0 | 199 | 0 |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo | 0 | 65 | 0 |
| other | Decreased appetite | Metabolism and nutrition disorders | Rifamycin SV MMX | 1 | 199 | 1 |
| other | Insomnia | Psychiatric disorders | Placebo | 0 | 65 | 0 |
| other | Insomnia | Psychiatric disorders | Rifamycin SV MMX | 1 | 199 | 1 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 65 |
| Total, all-cause mortality | Rifamycin SV MMX | 0 | 199 |
| Total, other adverse events | Placebo | 25 | 65 |
| Total, other adverse events | Rifamycin SV MMX | 58 | 199 |
| Total, serious adverse events | Placebo | 1 | 65 |
| Total, serious adverse events | Rifamycin SV MMX | 2 | 199 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rifamycin SV MMX vs Placebo: Clinical Cure | Trial comparisons |
| Rifamycin SV MMX vs Placebo: deaths from any cause | Trial comparisons |
| Rifamycin SV MMX vs Placebo: serious adverse events | 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.
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/NCT01142089
GET https://conductscience.org/api/trials/v1/NCT01142089/events?page=2