Trial · NCT01208922
Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea
NCT01208922, Phase 3, Completed, Dr. Falk Pharma GmbH; results first posted 2019-02-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea. Trials, record NCT01208922. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01208922
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea
- NCT number
- NCT01208922
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 835 participants, actual
- Lead sponsor
- Dr. Falk Pharma GmbH
- Conditions
- Traveler's Diarrhea
- Interventions
- Rifamycin SV-MMX®, Ciprofloxacin
- First posted
- 2010-09-24
- Last updated
- 2019-02-27
- Results first posted
- 2019-02-27
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) | 5 days | Time to Last Unformed Stool (TLUS), defined as the interval in hours between the first dose of study drug and the last unformed stool passed, after which clinical cure was declared. |
| Secondary | Number of Patients With Clinical Cure | 5 days | Clinical Cure Rate: 24-hour period with no clinical symptoms except mild flatulence, no fever, no watery stools and no more than 2 soft stools OR 48-hour period with no stools or only formed stools, and no fever, with our without 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) | 5 days | Efficacy results were reported for Full Analysis Set, which all randomised patients (as randomised) who received at least one dose of study medication. Patients with uncertainty as to whether they had received study medication or not (e.g., due to lost to follow-up) were included. | hours | MEDIAN |
| SECONDARY | Number of Patients With Clinical Cure | 5 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
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) | Group A | 44.3 | 95% Confidence Interval 40.1 to 47.5 | hours | |
| Time to Last Unformed Stool (TLUS) | Group B | 40.3 | 95% Confidence Interval 33.5 to 44.8 | hours | |
| Number of Patients With Clinical Cure | Group A | 357 | Participants | ||
| Number of Patients With Clinical Cure | Group B | 352 | 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 | Rifamycin Group | 420 | |
| Overall Study | STARTED | Ciprofloxacin Group | 415 | |
| Overall Study | COMPLETED | Rifamycin Group | 409 | |
| Overall Study | COMPLETED | Ciprofloxacin Group | 405 | |
| Overall Study | NOT COMPLETED | Rifamycin Group | 11 | |
| Overall Study | NOT COMPLETED | Ciprofloxacin Group | 10 |
Source ClinicalTrials.gov
Adverse events10
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 | Headache | Nervous system disorders | Group A | 13 | 420 | 13 |
| other | Headache | Nervous system disorders | Group B | 9 | 415 | 9 |
| other | Diarrhoea | Gastrointestinal disorders | Group A | 8 | 420 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | Group B | 6 | 415 | 6 |
| other | Nausea | Gastrointestinal disorders | Group A | 6 | 420 | 6 |
| other | Nausea | Gastrointestinal disorders | Group B | 6 | 415 | 6 |
| other | Flatulence | Gastrointestinal disorders | Group A | 5 | 420 | 5 |
| other | Flatulence | Gastrointestinal disorders | Group B | 6 | 415 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Group A | 4 | 420 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Group B | 5 | 415 | 5 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A | 0 | 420 |
| Total, all-cause mortality | Group B | 0 | 415 |
| Total, other adverse events | Group A | 36 | 420 |
| Total, other adverse events | Group B | 32 | 415 |
| Total, serious adverse events | Group A | 0 | 420 |
| Total, serious adverse events | Group B | 0 | 415 |
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 |
|---|---|
| Group A vs Group B: Number of Patients With Clinical Cure | Trial comparisons |
| Group A vs Group B: deaths from any cause | Trial comparisons |
| Group A vs Group B: 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/NCT01208922
GET https://conductscience.org/api/trials/v1/NCT01208922/registered