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The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.
To determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Rifaximin |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment | The efficacy of 14 days of rifaximin 600 mg once daily (QD) compared with placebo when taken by healthy subjects to prevent travelers' diarrhea (TD) resulting from all causes. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of San Diego | Guadalajara | Jalisco | 45090 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20412178 | Derived | Martinez-Sandoval F, Ericsson CD, Jiang ZD, Okhuysen PC, Romero JH, Hernandez N, Forbes WP, Shaw A, Bortey E, DuPont HL. Prevention of travelers' diarrhea with rifaximin in US travelers to Mexico. J Travel Med. 2010 Mar-Apr;17(2):111-7. doi: 10.1111/j.1708-8305.2009.00385.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm 1 | Rifaximin 600 MG QD |
| FG001 | Placebo Arm | Matching Placebo 600MG QD |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm 1 | Rifaximin 600 MG QD |
| BG001 | Placebo Arm | Matching Placebo 600MG QD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment | The efficacy of 14 days of rifaximin 600 mg once daily (QD) compared with placebo when taken by healthy subjects to prevent travelers' diarrhea (TD) resulting from all causes. | The Intent to Treat (ITT) population received at least 1 dose of the study drug. For the ITT population, 99 participants were in the rifaximin group and 102 were in the placebo group. The EE consisted of105 of 106 subjects and the placebo group, 100 of 104 subjects were EE. All subject included in Safety analysis | Posted | Count of Participants | Participants | 14 days |
|
14 days
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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 | Treatment Arm | Rifaximin 600 MG QD |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valeant Pharmaceuticals | Valeant Pharmaceuticals | (866) 246-8245 |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D004405 | Dysentery, Bacillary |
| D004927 | Escherichia coli Infections |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004756 | Enterobacteriaceae Infections |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Placebo Placebo |
|
|
| 0 |
| 106 |
| 81 |
| 106 |
| EG001 | Placebo | Matching Placebo 600MG QD | 0 | 104 | 93 | 104 |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Defecation Urgency | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Rectal tenesmus | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Hematochezia | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| headache | Nervous system disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 7.1 | Non-systematic Assessment |
|
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| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D004403 | Dysentery |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |