A Phase 4 interventional study of Fosaprepitant for Injection and Metoclopramide Injection in Nausea and Vomiting, Nausea and Vomiting, sponsored by Montefiore Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Montefiore Medical Center · Phase 4, Interventional, and Treatment
The study team proposes a double-blind, comparative effectiveness, randomized controlled trial (RCT) to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic metoclopramide. 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 emergency departments (EDs). Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time.
Nausea and vomiting (NV) are common and interrelated conditions. Approximately 50% of adults experience nausea in a given year while 30% of adults experience vomiting over the same period. Of this population of symptomatic individuals with NV, 25% of patients seek care in any healthcare delivery setting. Health Care Utilization Project (HCUP) data indicates that nearly 9.0 million patients seek care for NV in EDs each year in the United States.
Antiemetics are used to treat NV. Antiemetics currently utilized in the emergency department setting for NV do not always work on the first dose and have a plethora of side effects because of their peripheral mechanism of action outside of the vomiting reflex pathway in the central nervous system. These medications include ondansetron, promethazine, metoclopramide, olanzapine, haloperidol. Chief among these side effects is alteration of an aspect cardiac electrical signaling called the QT segment which represents the duration of ventricular contraction and relaxation. The QT segment is prolonged with commonly used antiemetics which can often be a prelude to cardiac dysrhythmias that are associated with mortality. As a result, patients with NV often have long length-of-stay (LOS) involving supportive care with intravenous fluids or empiric treatment with medications that can potentiate development of cardiac dysrhythmias. This is a problem in busy emergency departments (EDs) struggling to accelerate patient throughput in order to appropriately keep up with patient volume in an under-supplied hospital bed environment nationally.
644 studies on the registry are indexed under Nausea; 85 are open to participants now.
This study's planned enrollment of 212 is above the median of 96 across 544 interventional studies indexed under Nausea.
Browse Nausea studies →Montefiore Medical Center is the lead sponsor of 416 studies on the registry; 69 are open to participants now.
Of its 87 completed or terminated interventional studies of FDA-regulated products, 76 (87%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fosaprepitant
Drug: Fosaprepitant for Injection
Metoclopramide
Drug: Metoclopramide Injection
Fosaprepitant 150mg IV administered over 15 minutes
Metoclopramide 10mg IV administered over 15 minutes
Also known as: Reglan
Sustained Nausea and Vomiting (NV) Relief
The primary efficacy outcome for this study will be sustained relief from NV at 2 hours following medication administration. Sustained relief from NV will be determined by the intensity of nausea reported by patients following administration of antiemetic. Intensity of nausea will be reported as either "None", "Mild", "Moderate" or "Severe." The number/percentage of patients reporting each degree of nausea intensity at 2 hours will be summarized by study arm. Sustained relief of NV requires a patient to present with a nausea intensity of either "Severe" or "Moderate," which is then reduced by treatment to at least "Mild" or None," within 2 hours of medication administration without the use of any rescue medication. Patients who do not report an initial nausea intensity of either "Severe" or "Moderate" will not be assessed as they are not eligible for the study.
Time frame: 2 hours (assessed at the 2-hour mark after administration of the intervention)
Development of New Symptom
The primary tolerability outcome for this study will be the onset of any new symptoms within 2 hours after medication administration. Onset of symptoms will be assessed by asking patients if they developed any new symptoms after administration of the investigational medication. Symptoms will be elicited using an open-ended format. Patients who confirmed that they had experienced new symptoms will be asked to grade the severity of the new symptom(s) using the descriptors "Mild", "Moderate", or "Severe". The frequency and intensity of new symptoms will be summarized by study arm using basic descriptive statistics.
Time frame: 2 hours (assessed at the 2-hour mark after administration of the intervention)
Sustained NV Relief
Sustained relief from NV will be determined by the intensity of nausea reported by patients following administration of antiemetic. Intensity of nausea will be reported as either "None", "Mild", "Moderate" or "Severe." The number/percentage of patients reporting each degree of nausea intensity at 24 hours will be summarized by study arm. Sustained relief of NV requires a patient to present with a nausea intensity of either "Severe" or "Moderate," which is then reduced by treatment to at least "Mild" or "None," within 2 hours of medication administration AND maintained at "Mild" or "None" level for the entire 24-hour period following medication administration, without the use of rescue medication.
Time frame: 24 hours following medication administration
NV Relief
Relief of NV over time will be determined by the intensity of nausea reported by patients following administration of antiemetic. Intensity of nausea will be reported as either "None", "Mild", "Moderate" or "Severe" and assessed every 15 minutes during the first 2 hours, then every hour after that up to 24 hours. The number/percentage of patients reporting each degree of nausea intensity at each timepoint will be summarized by study arm using basic descriptive statistics. Sustained relief of NV requires a patient to present with an initial nausea intensity of either "Severe" or "Moderate" and assessments will only be made in patients who did not need rescue medication.
Time frame: 24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until final disposition; reassessed at 24 hours)
NV Freedom
Freedom from NV over time will be determined by the intensity of nausea reported by patients following administration of antiemetic. Intensity of nausea will initially be reported as either "None", "Mild", "Moderate" or "Severe" and assessed every 15 minutes during the first 2 hours, then every hour after that up to 24 hours. The number/percentage of patients reporting a nausea intensity of "None" will be summarized by study arm using basic descriptive statistics. Sustained freedom from NV requires a patient to present with an initial nausea intensity of either "Severe" or "Moderate" and assessments will only be made in patients who did not receive rescue medication.
Time frame: 24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until final disposition; reassessed at 24 hours)
Sustained NV Freedom
Sustained NV Freedom will be determined by the intensity of nausea reported by patients following administration of antiemetic. Intensity of nausea will initially be reported as either "None", "Mild", "Moderate" or "Severe." The number/percentage of patients reporting a nausea intensity of "None" will be summarized by study arm using basic descriptive statistics. Sustained NV Freedom requires a patient to present with a nausea intensity of either "Severe" or "Moderate," which is then reduced by treatment to "None" within 2 hours of medication administration AND maintained at the same ("None") level for the entire 24-hour period following medication administration, without the use of rescue medication.
Time frame: 24 hours following medication administration
Medication Preference
Patient preference for receiving the same antiemetic medication as was administered during the study in the event of a subsequent episode of NV will be assessed during a follow-up phone call. Patients will be asked, "The next time you come to the ED for treatment of nausea and vomiting, do you want to receive the same medication again?" Patients will select from the following responses ("Yes," "No," or "Not sure"). Patient responses will be summarized and reported by study arm using basic descriptive statistics.
Time frame: 24 hours
Duration of ED Stay
Mean duration of ED stay, defined as the interval of time from initial presentation in ED to disposition, will be determined. ED durations will be summarized and reported by study arm using basic descriptive statistics. Prolonged LOS is generally associated with increased treatment complications and less favorable outcomes.
Time frame: Initial presentation to disposition, approximately 4 hours
Severity of Nausea
Severity of nausea will be evaluated based on responses to a visual analogue scale ranging from 0 to 100 (0 = no nausea, 100 = worst nausea possible). Mean scores will be summarized and reported by study arm. Higher scores are associated with increased severity of nausea.
Time frame: 24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until disposition; reassessed at 24 hours)
QTc Interval (QT interval corrected for heart rate)
Mean QTc durations, as calculated from electrocardiogram (ECG) readings administered prior to receiving intervention, and at disposition, will be determined. Mean QTc durations will be summarized by study arm. Prolonged QT interval is commonly associated with antiemetics and can often be a prelude to cardiac dysrhythmias associated with mortality.
Time frame: Prior to Intervention and at disposition, approximately 2 hours
Need for rescue antiemetic medication
The need for rescue antiemetic medication during the study will be assessed using a binary outcome (i.e., "Yes: or "No") to summarize whether additional dosing of antiemetic medication to treat nausea was needed. Results will be summarized by study arm using basic descriptive statistics.
Time frame: 2 hours (assessed at the 2-hour mark after administration of the intervention)
Vomiting Episodes
The mean number of vomiting episodes per patient over the past 24 hours will be assessed and summarized by study arm.
Time frame: Up to 24 hours
Hospitalization
The percentage of patients who required hospitalization within 24 hours due to NV symptoms will be determined and summarized by study arm. Hospitalizations are associated with increased complications and less favorable outcomes.
Time frame: Up to 24 hours
Need for Fluid Treatment
The percentage of patients treated with intravenous (IV) fluids will be determined and summarized by study arm. The need for IV fluids is associated with increased supportive care, increased hospital LOS and less favorable outcomes.
Time frame: 4 hours
Mean Fluid Volume
For patients requiring IV fluids, the mean per patient volume of IV fluids administered will be summarized and reported by study arm. The need for, and increased volumes of, IV fluids is associated with increased supportive care, increased hospital LOS and less favorable outcomes.
Time frame: 4 hours
Revisit Rate to Emergency Department
For purposes of this study, revisit rate will be defined as the number/percentage of participants requiring a revisit to the ED for additional evaluation and management of NV. Results will be summarized by study arm using basic descriptive statistics. More frequent revisit rates are associated with increased complications and less favorable outcomes.
Time frame: 24 hours
Plan to share: Undecided
Start is estimated for Dec 2026; primary completion for Sep 2027, 9 months later.
Of 27 phase 4 interventional studies under Nausea, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 24. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Fosaprepitant