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Nausea and VomitingPhase 4BARF RCTNCT06740812

Broadening Antiemetics Research by Comparing the Effectiveness of Fosaprepitant and Metoclopramide

A Phase 4 study testing Fosaprepitant for Injection and Metoclopramide Injection in people with Nausea and Vomiting and Nausea, run by Montefiore Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nausea and Vomiting, Nausea, Vomiting
What is being tested?
Fosaprepitant for Injection and Metoclopramide Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
1 siteUnited States
Study dates
Dec 2026to Sep 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults at least 18 years old
  • Present to ED for treatment of Nausea and/or vomiting as defined by the International Classification of Diseases (ICD-10) or identified by treating clinician

Who cannot join

  • Pregnancy, desiring pregnancy, or lactating
  • Antiemetic use or intravenous fluids prior to presenting to ED for evaluation and management
  • Bradycardia (< 60 bpm heart rate)
  • Prolonged QTc (greater than 490ms)
  • Not conversant in English or Spanish
  • Altered mental status
  • Dementia
  • Lack of phone for follow-up communication

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mustfa K Manzur, MD MPH MS contact

718-920-6626

mmanzur@montefiore.org

United States1 site

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Campus IRB, 718-430-2237, clinicaltrials.gov@einsteinmed.edu

    Mustfa K Manzur, MD MPH MS

Other trials in United States

About this study

Official title: Broadening Antiemetics Research by Comparing the Effectiveness of Fosaprepitant and Metoclopramide: A Randomized Control Trial

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.

Read the detailed description

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.

Being tested
Fosaprepitant for Injection, Metoclopramide Injection
Keywords
Signs and Symptoms, Digestive, Antiemetics, Autonomic Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Gastrointestinal Agents, Antipruritics, Dermatologic Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Neurokinin-1 Receptor Antagonists, Fosaprepitant, Aprepitant, Dopamine Receptor Antagonist, Randomized Control Trial, Metoclopramide, Adults
Medical subject headings
Nausea, Vomiting, Signs and Symptoms, Digestive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fosaprepitant for InjectionDrug

    Fosaprepitant 150mg IV administered over 15 minutes

  • Metoclopramide InjectionDrug

    Also called Reglan

    Metoclopramide 10mg IV administered over 15 minutes

Study groups in NCT06740812
Study groupRoleWhat they receive
Investigational InterventionExperimentalFosaprepitant
Receives: Drug: Fosaprepitant for Injection
Standard-of-Care InterventionActive comparatorMetoclopramide
Receives: Drug: Metoclopramide Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 hours (assessed at the 2-hour mark after administration of the intervention)

  2. 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.

    Measured: 2 hours (assessed at the 2-hour mark after administration of the intervention)

Secondary outcomes (6)

  1. 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.

    Measured: 24 hours following medication administration

  2. 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.

    Measured: 24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until final disposition; reassessed at 24 hours)

  3. 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.

    Measured: 24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until final disposition; reassessed at 24 hours)

  4. 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.

    Measured: 24 hours following medication administration

  5. 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.

    Measured: 24 hours

  6. 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.

    Measured: Initial presentation to disposition, approximately 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2024
  2. Study startDec 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06740812
Sponsor's protocol ID
2024-16422
Acronym
BARF RCT
Status last verified
Jun 2026
First submitted
14 Dec 2024
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Mechanisms and Control of Emesis: A Satellite Symposium of the European Neuroscience Association: Proceedings of an International Meeting Held in Marseille (France), 4-7 September 1992. John Libbey Eurotext

  • Singh P, Yoon SS, Kuo B. Nausea: a review of pathophysiology and therapeutics. Ther Adv Gastroenterol. 2016 Jan;9(1):98-112. doi: 10.1177/1756283X15618131.

    PubMed 26770271

  • Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Available from http://www.ncbi.nlm.nih.gov/books/NBK52651/

    PubMed 21413206

  • Pourmand A, Mazer-Amirshahi M, Chistov S, Sabha Y, Vukomanovic D, Almulhim M. Emergency department approach to QTc prolongation. Am J Emerg Med. 2017 Dec;35(12):1928-1933. doi: 10.1016/j.ajem.2017.08.044. Epub 2017 Aug 24.

    PubMed 28855066

  • Franklin BJ, Vakili S, Huckman RS, Hosein S, Falk N, Cheng K, Murray M, Harris S, Morris CA, Goralnick E. The Inpatient Discharge Lounge as a Potential Mechanism to Mitigate Emergency Department Boarding and Crowding. Ann Emerg Med. 2020 Jun;75(6):704-714. doi: 10.1016/j.annemergmed.2019.12.002. Epub 2020 Jan 23.

    PubMed 31983501

  • Aapro M, Carides A, Rapoport BL, Schmoll HJ, Zhang L, Warr D. Aprepitant and fosaprepitant: a 10-year review of efficacy and safety. Oncologist. 2015 Apr;20(4):450-8. doi: 10.1634/theoncologist.2014-0229. Epub 2015 Mar 20.

    PubMed 25795636

  • Langford P, Chrisp P. Fosaprepitant and aprepitant: an update of the evidence for their place in the prevention of chemotherapy-induced nausea and vomiting. Core Evid. 2010 Oct 21;5:77-90. doi: 10.2147/ce.s6012.

    PubMed 21042544

  • Furyk JS, Meek RA, Egerton-Warburton D. Drugs for the treatment of nausea and vomiting in adults in the emergency department setting. Cochrane Database Syst Rev. 2015 Sep 28;2015(9):CD010106. doi: 10.1002/14651858.CD010106.pub2.

    PubMed 26411330

  • Yang Y, Yang N, Wu L, Ouyang Q, Fang J, Li J, Liao W, Cai K, Huang J, Li J, Zhang Y, Wang X, Zhang H, Xu N, Zhao Q, Hu X, Li W, Zhong W, Zhong D, Cheng G, Ye S, Zhong M, Wang D, Liu H, Zheng J, Liu X, Xu H, Zhang L. Safety and efficacy of aprepitant as mono and combination therapy for the prevention of emetogenic chemotherapy-induced nausea and vomiting: post-marketing surveillance in China. Chin Clin Oncol. 2020 Oct;9(5):68. doi: 10.21037/cco-20-160.

    PubMed 33161724

  • Braude D, Soliz T, Crandall C, Hendey G, Andrews J, Weichenthal L. Antiemetics in the ED: a randomized controlled trial comparing 3 common agents. Am J Emerg Med. 2006 Mar;24(2):177-82. doi: 10.1016/j.ajem.2005.08.017.

    PubMed 16490647

  • Cham S, Basire M, Kelly AM. Intermediate dose metoclopramide is not more effective than standard dose metoclopramide for patients who present to the emergency department with nausea and vomiting: a pilot study. Emerg Med Australas. 2004 Jun;16(3):208-11. doi: 10.1111/j.1742-6723.2004.00588.x.

    PubMed 15228463

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fosaprepitant for Injection and Metoclopramide Injection in people with Nausea and Vomiting and Nausea, run by Montefiore Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mustfa K Manzur, MD MPH MS (718-920-6626, mmanzur@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustained Nausea and Vomiting (NV) Relief (time frame: 2 hours (assessed at the 2-hour mark after administration of the intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06740812, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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