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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00857090 | Pharmacokinetic, Safety and Efficacy Study of OMS201 in Subjects Undergoing Retrograde Ureteroscopic Removal of Upper Urinary Tract Stones | PHASE1 | COMPLETED | 18 | — | — | Mar 1, 2009 | Dec 1, 2010 | Oct 12, 2012 | 4 | United States |
| NCT00599664 | Pharmacokinetic and Safety Study of OMS201 in Subjects Undergoing Ureteroscopic Treatment for Removal of Urinary Tract-Located Stones | PHASE1 | COMPLETED | 11 | — | — | Dec 1, 2007 | Sep 1, 2008 | Apr 30, 2010 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Drug |
| 2 | PLACEBO_COMPARATOR | Vehicle |
| Name | Type | Description |
|---|---|---|
| OMS201 | DRUG | Stage 1: OMS201 irrigation solution at 3X the base concentration during surgery Stage 2: OMS201 irrigation solution up to 10X the base concentration during surgery |
| Vehicle | DRUG | Stages 1-2: Vehicle irrigation solution during surgery |
Inclusion Criteria: * 18 - 65 years of age. * Subject is undergoing retrograde ureteroscopic removal of renal-collecting system or ureteral stones for which general anesthesia will be used. Exclusion Criteria: * No allergies to any of the individual ingredients in OMS201. * Subject taking a prohi...