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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00468728 | PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) | PHASE3 | COMPLETED | 535 | — | — | Oct 4, 2006 | Dec 11, 2009 | Apr 21, 2017 | 116 | United States, Belgium +7 |
Percentage of subjects with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Vancomycin |
| 2 | EXPERIMENTAL | PAR-101/OPT-80 |
| Name | Type | Description |
|---|---|---|
| PAR-101/OPT-80 | DRUG | capsules |
| Vancomycin | DRUG | Capsules |
Inclusion Criteria: * Males/females with CDAD * Females must use adequate contraception * Signed informed consent Exclusion Criteria: * Life-threatening CDAD * Toxic megacolon * Pregnant * Concurrent use of diarrheal agents * Participation in other trials