protocolSection identificationModule nctId: NCT06382012, orgStudyIdInfo id: 2024-15703, briefTitle: Antiemetic Fosaprepitant To Remedy Nausea and Vomiting, acronym: AFTR NV RCT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Montefiore Medical Center, class: OTHER, descriptionModule briefSummary: The study team proposes a randomized, double-blind, RCT to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic ondansetron. Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin (NK-1) which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex. Currently, fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration (USFDA) approved indications for nausea and vomiting: chemotherapy-induced and postoperative. Neurokinin inhibitors are highly effective and generally well-tolerated. Therefore, this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in EDs. Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time. The outcome for the efficacy analysis will be no need for additional medication to treat nausea and vomiting within 2 hours of investigational medication administration. The primary outcome for the tolerability analysis will be the development of any new symptom within 2 hours of medication administration., conditionsModule conditions: Nausea and Vomiting, conditions: Nausea, conditions: Vomiting, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Fosaprepitant 150 mg, interventions name: Ondansetron 4 mg, outcomesModule primaryOutcomes measure: Sustained Relief from NV, secondaryOutcomes measure: Severity of Nausea, secondaryOutcomes measure: Need for rescue antiemetic medication, secondaryOutcomes measure: Medication Preference, secondaryOutcomes measure: Functional disability, secondaryOutcomes measure: Vomiting, secondaryOutcomes measure: Hospitalization, secondaryOutcomes measure: Fluid Treatment, secondaryOutcomes measure: Mean Fluid Volume, secondaryOutcomes measure: Length of Stay, secondaryOutcomes measure: QTc Interval (QT interval corrected for heart rate), secondaryOutcomes measure: Revisit Rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Montefiore Medical Center (Montefiore and Weiler EDs), city: Bronx, state: New York, zip: 10467, country: United States, contacts name: Mustfa K Manzur, MD, role: CONTACT, phone: 718-920-6626, email: mmanzur@montefiore.org, geoPoint lat: 40.84985, lon: -73.86641, hasResults: False