drugset / Trial / NCT00539721
A Randomized Controlled Study of Rolapitant for the Prevention of Nausea and Vomiting Following Surgery (Study P04937AM1)(COMPLETED)
RandomizedParallel-groupDouble-blindPrevention
Summary
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.
Timeline
- Start
- 2007-10
- Primary completion
- 2008-07
- Completion
- 2008-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ondansetron | Other / unclassified | 4 mg | Intravenous |
| Subject | Rolapitant | Small molecule | 5 mg | Oral |
| Subject | Rolapitant | Small molecule | 20 mg | Oral |
| Subject | Rolapitant | Small molecule | 70 mg | Oral |
| Subject | Rolapitant | Small molecule | 200 mg | Oral |
Indications
No indication recorded.