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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02092935 | A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD) | PHASE2 | COMPLETED | 100 | — | — | Apr 1, 2014 | Oct 1, 2015 | Oct 20, 2016 | 26 | United States, Canada |
Sustained clinical response is defined as clinical cure at the Test of Cure Visit (Day 12) and no recurrence of CDAD within 30 days of End of Therapy
| Arm | Type | Description |
|---|---|---|
| SMT19969 | EXPERIMENTAL | 200 mg capsule of SMT19969 twice a day for 10 days with alternating 200 mg placebo twice a day |
| Vancomycin | ACTIVE_COMPARATOR | 125 mg capsule four times a day for 10 days |
| Name | Type | Description |
|---|---|---|
| SMT19969 | DRUG | - |
| Vancomycin | DRUG | - |
Inclusion Criteria: * Informed consent * Clinical diagnosis of CDAD plus laboratory diagnostic test * No more than 24 hrs antimicrobial treatment for current CDAD episode * No more than 3 episodes of CDAD in prior 12 months * No previous episode of CDAD within 30 days of study enrollment * Female s...