500 Boylston Street, Boston, MA 02116 617-419-4700
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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.
Ages:18 - 75
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.
Sponsor: Octagon Research Solutions, Inc.
Phase: Phase 2
Trial ID: NCT01507194
Not Accepting Healthy Volunteers