Postoperative Nausea and Vomiting
Conditions
Brief 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.
Interventions
DRUGOndansetron
Single IV dose
DRUGVestipitant
Single IV dose
Sponsors
Accenture
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response | 10 min. after infusion start through 24 hrs. or discharge | No emesis and no further rescue medication |
Secondary
| Measure | Time frame |
|---|---|
| Nausea Numeric Rating Scale (NNRS) | Pre-dose; 5, 10, 15 min. post-dose; q 15 min. through 2 hrs. post-dose; q 2 hrs. through 24 hrs. post-dose; and 5 days post-dose |
| No Emesis/Vomiting | Pre-dose; continuous through 24 hrs. post-dose; and 5 days post-dose |
Countries
United States
Outcome results
None listed