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The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus Ciprofloxacin for the treatment of adults with traveller's diarrhoea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Rifamycin SV-MMX® 200 mg tablets |
|
| Group B | Active Comparator | Ciprofloxacin 500 mg capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifamycin SV-MMX® | Drug | 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Last Unformed Stool (TLUS) | 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. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Clinical Cure | 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. | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Professor Robert Steffen, M. D. | University of Zurich, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 401 | Quito | Ecuador | ||||
| Site 200 |
A total of 835 patients were enrolled and were randomised to one of the 2 treatment groups according to the randomisation plan. All randomised patients received at least one dose of study medication.
Recruited from November 2010 until January 2016
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| ID | Title | Description |
|---|---|---|
| FG000 | Rifamycin Group | Rifamycin SV-MMX® 200 mg tablets Rifamycin SV-MMX®: 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d. |
| FG001 | Ciprofloxacin Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Ciprofloxacin | Drug | 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d. |
|
| Quetzaltenango |
| Guatemala |
| Site 101 | Mapusa | Karaswada | India |
| Site 124 | Ajmer | India |
| Site 118 | Bardez | India |
| Site 120 | Calangute | India |
| Site 104 | Hyderabad | India |
| Site 114 | Kolkata | India |
| Site 116 | Lucknow | India |
| Site 107 | Madgaon | India |
| Site 110 | Madgaon | India |
| Site 123 | New Delhi | India |
| Site 122 | Panjim | India |
| Site 102 | Puducherry | India |
| Site 115 | Pushkar | India |
| Site 119 | Salcette | India |
| Site 111 | Tiswadi | India |
| Site 109 | Varanasi | India |
| Site 103 | Vijayawada | India |
Ciprofloxacin 500 mg capsules
Ciprofloxacin: 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.
| COMPLETED |
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| NOT COMPLETED |
|
Baseline results were reported for Full Analysis Set, which included 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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Rifamycin SV-MMX® 200 mg tablets Rifamycin SV-MMX®: 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d. |
| BG001 | Group B | Ciprofloxacin 500 mg capsules Ciprofloxacin: 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Last Unformed Stool (TLUS) | 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. | 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. | Posted | Median | 95% Confidence Interval | hours | 5 days |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Patients With Clinical Cure | 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. | Posted | Count of Participants | Participants | 5 days |
|
|
An average of 1 month
Non-serious AEs were analysed as Treatment-Emergent AEs defined as all AEs with onset after treatment day 1 but not after the last day with study drug administration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | Rifamycin SV-MMX® 200 mg tablets Rifamycin SV-MMX®: 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d. | 0 | 420 | 0 | 420 | 36 | 420 |
| EG001 | Group B | Ciprofloxacin 500 mg capsules Ciprofloxacin: 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d. | 0 | 415 | 0 | 415 | 32 | 415 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Department of Clinical Research | Dr. Falk Pharma GmbH | 0049 7611514 | 0 | zentrale@drfalkpharma.de |
| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Guatemala |
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| India |
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