a study of vestipitant (gw597599) in the treatment of breakthrough postoperative nausea and vomiting (ponv)

Conditions: Postoperative Nausea and Vomiting

Summary: this study will evaluate single iv doses of vestipitant (gw597599) compared to 4 mg iv ondansetron for treating breakthrough postoperative nausea and vomiting (ponv) after failure of ponv prophylaxis with a regimen that includes 4 mg iv ondansetron.


Eligibility criteria:
inclusion criteria: * male or female post-operative surgical subjects between the ages of 18-75 years. * female subject is of non-childbearing potential or of child-bearing potential and agrees to use specified contraception methods. * has 3 or more of the following independent risk factors for ponv: female gender; non-smoker; history of ponv or motion sickness; or planned post- operative opioids. * has received one dose of ondansetron as part of a ponv prophylaxis regimen for the surgical procedure. * has received general anesthesia. * meets asa physical status classification of 1 or 2 without an "e" modifier preoperatively on the day of surgery and has hematology and blood chemistry values within acceptable limits for surgery. * is capable of giving written informed consent. * experiences breakthrough ponv defined as: post-operative nausea of ≥ 7 on the nausea numeric rating scale; nausea resulting in a subject request for an anti-emetic; or an episode of emesis or retching. exclusion criteria: * a history of hiv. * a positive pre-study hepatitis b surface antigen or positive hepatitis c antibody result within 3 months of screening. * an alt or ast \>2.5 x uln at screening. * pregnant or lactating females. * the subject is scheduled to undergo a laparoscopic biopsy only. * the subject has a history of or is scheduled to undergo cardiac/cardiothoracic surgery. * the subject is scheduled to receive neuraxial anesthesia(e.g., epidural, spinal, or caudal anesthesia)or total iv anesthesia. * the subject is scheduled to receive propofol for maintenance of anesthesia (propofol as an induction agent is allowed). * the subject is scheduled to receive an nk1 inhibitor (aprepitant/fosaprepitant) as part of a ponv prophylaxis regimen for the surgical procedure. * the subject is scheduled to have gastric contents suctioned continuously during the surgical procedure via a nasogastric tube, or a nasogastric or oral gastric tube during the post-operative period. a single pass at the beginning or at the end of the procedure, and intraoperative gastric suctioning of air, will be permitted. * the subject received an investigational drug within 30 days or was scheduled to receive any investigational drug in addition to vestipitant during the study period. * the subject has persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to, gastric outlet obstruction, hypercalcemia, active peptic ulcer, increased intracranial pressure, chemotherapy, or brain metastases. * the subject received radiation therapy to the abdomen or the pelvis within 7 days prior to receiving study medications and/or received radiation therapy to the abdomen or the pelvis in the evaluation period. * the subject has a history of wound dehiscence. * the subject has a history of any other illness which might pose an unacceptable risk by administering study medication. * the subject has any current or past medical condition (e.g., vagotomy) and/or required medication to treat a condition that could affect the evaluation of the study. * the subject has a known contraindication or hypersensitivity to ondansetron or ondansetron injection, any scheduled anaesthetic or analgesic agents, vestipitant or any component of the vestipitant formulation including captisol. * the subject received medication with known or potential antiemetic activity after the induction of anaesthesia (during the intraoperative or post- operative period) other than the planned study treatment. * current or planned use of strong or moderate inhibitors of cyp3a within 7 days or inducers of cyp3a within 14 days prior to study medication administration. * the subject is unwilling or unable to follow the procedures outlined in the protocol. * the subject is mentally or legally incapacitated.