Broadening Antiemetics Research by Comparing the Effectiveness of Fosaprepitant and Metoclopramide

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT06740812
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Nausea
  • Nausea and Vomiting
  • Vomiting

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fosaprepitant for Injection — DRUG
    Fosaprepitant 150mg IV administered over 15 minutes
  • Metoclopramide Injection — DRUG
    Metoclopramide 10mg IV administered over 15 minutes

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Sep 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
212 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational Intervention
    Fosaprepitant
  • Active Comparator: Standard-of-Care Intervention
    Metoclopramide

Primary Outcome Measure

Sustained Nausea and Vomiting (NV) Relief [ Time Frame: 2 hours (assessed at the 2-hour mark after administration of the intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10467
Campus IRB
[email protected]
718-430-2237
Mustfa K Manzur, MD MPH MS (PRINCIPAL_INVESTIGATOR)

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By research site
Montefiore Medical Center· The Bronx, NY

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