A Randomized, Double-Blind, Double-Dummy, Dose-Ranging, Active- and Placebo-Controlled Study of Single-Dose Oral Rolapitant Monotherapy for the Prevention of Postoperative Nausea and Vomiting (PONV)
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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Rolapitant Dose 1
- drug : Rolapitant Dose 2
- drug : Placebo
- drug : Rolapitant Dose 4
- drug : Ondansetron
- drug : Rolapitant Dose 3
Phase: Phase 2
Ages Eligible For Study:
- 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 least 24 hours - Women expected to require postoperative intravenous opioid PCA. - Women whose surgery is expected to require at least 1 hour, but not more than 4 hours, of general anesthesia using the regimen defined in this protocol. - Women of childbearing potential who have a negative pregnancy test or women who have been surgically sterilized or are postmenopausal.