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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00539721 | A Randomized Controlled Study of Rolapitant for the Prevention of Nausea and Vomiting Following Surgery (Study P04937AM1)(COMPLETED) | PHASE2 | COMPLETED | 619 | — | — | Oct 1, 2007 | Jul 1, 2008 | Nov 1, 2013 | - | — |
| Arm | Type | Description |
|---|---|---|
| Rolapitant Dose 1 | EXPERIMENTAL | - |
| Rolapitant Dose 2 | EXPERIMENTAL | - |
| Rolapitant Dose 3 | EXPERIMENTAL | - |
| Rolapitant Dose 4 | EXPERIMENTAL | - |
| Ondansetron | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Rolapitant Dose 1 | DRUG | Rolapitant 5 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1 |
| Rolapitant Dose 2 | DRUG | Rolapitant 20 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1 |
| Rolapitant Dose 3 | DRUG | Rolapitant 70 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1 |
| Rolapitant Dose 4 | DRUG | 200 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1 |
| Ondansetron | DRUG | Ondansetron 4 mg x 1 intravenous and rolapitant placebo (4 capsules) x 1 oral on Day 1 |
| Placebo | DRUG | Rolapitant placebo (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1 |
Inclusion Criteria: * Women aged 18 years or older of any race with an American Society of Anesthesiologists (ASA) physical status of I to III who are scheduled to undergo elective open abdominal surgery under general anesthesia. * Women whose postoperative hospitalization is expected to last at le...