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This is a multicenter, randomized, controlled study in women who are having elective open abdominal surgery with general anesthesia and who are expected to need patient-controlled analgesia (PCA) after surgery. The primary objective is to assess the effect of rolapitant in the prevention of postoperative nausea and vomiting as measured by the prevention of vomiting in the first 24 hours after surgery. Participation in the study may last up to 3 months. The total duration of the study will be approximately 36 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rolapitant Dose 1 | Drug | Rolapitant 5 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| No emetic episodes regardless of rescue medication use. | First 24 hours after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
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