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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00196794 | A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea | PHASE3 | COMPLETED | 520 | — | — | Apr 1, 2005 | Aug 1, 2007 | Mar 19, 2014 | 138 | Australia, Austria +12 |
| NCT00106509 | A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea | PHASE3 | COMPLETED | 520 | — | — | Mar 1, 2005 | Feb 1, 2007 | Mar 5, 2015 | 140 | United States, Canada +1 |
| Name | Type | Description |
|---|---|---|
| Tolevamer potassium-sodium (GT267-004) | DRUG | - |
Inclusion Criteria: * 18 years of age and above * The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea * Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD * Baseline serum potassium \>...