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Broadening Antiemetics Research by Comparing the Effectiveness of Fosaprepitant and Metoclopramide

Study acronym: BARF RCT
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary and study completion dates: Feb 2027 to Sep 2027
    • Start date: May 2026 to Dec 2026
    v3
  2. Notable Phase: Phase 2/3 to Phase 4
    • Primary and study completion dates: Mar 2026 to Feb 2027
    • Start date: Jun 2025 to May 2026
    • Interventions: Fosaprepitant (Drug), Metoclopramide (Drug) to Fosaprepitant for Injection (Drug), Metoclopramide Injection (Drug)
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06740812
Lead Sponsor Montefiore Medical Center
Conditions
(from sponsor)
Nausea and Vomiting, Nausea, Vomiting
Related terms Nausea, Signs and Symptoms, Digestive, Vomiting
Enrollment 212 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov