Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01142089 | Study to Evaluate Safety and Efficacy of Rifamycin SV Multi-Matrix System (MMX) for the Treatment of Traveler's Diarrhea (TD) | PHASE3 | COMPLETED | 264 | — | — | May 27, 2010 | Jun 1, 2012 | Jun 8, 2018 | 12 | Guatemala, Mexico |
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.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo (two matching tablets) orally twice daily for 3 days (72 hours) |
| Rifamycin SV MMX | EXPERIMENTAL | Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours). |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo (two matching tablets) orally twice daily for 3 days (72 hours). |
| Rifamycin SV MMX | DRUG | Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours). |
Inclusion Criteria Patients were enrolled in the study only if they met all of the following criteria: 1. Male and female patients 18 years of age or older 2. Female and male patients of childbearing potential must have agreed to use an effective method of birth control (this method must have been...