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Broadening Antiemetics Research by Comparing the Effectiveness of Fosaprepitant and Metoclopramide (BARF RCT Trial)

Phase 2 & 3
Waitlist Available
Led By Benjamin Friedman, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until disposition; reassessed at 24 hours)
Awards & highlights
No Placebo-Only Group

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. 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.

Eligible Conditions
  • Nausea
  • Gastroenteritis
  • Nausea and Vomiting
  • Vomiting

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until disposition; reassessed at 24 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until disposition; reassessed at 24 hours) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Development of New Symptom
Sustained Nausea and Vomiting (NV) Relief
Secondary study objectives
Duration of ED Stay
Medication Preference
NV Freedom
+3 more
Other study objectives
Hospitalization
Mean Fluid Volume
Need for Fluid Treatment
+5 more

Side effects data

From 2015 Phase 3 trial • 942 Patients • NCT02106494
42%
Injection site bruising
31%
Injection site pain
22%
Constipation
21%
Fatigue
18%
Injection site nodule
17%
Injection site erythema
16%
Nausea
12%
Headache
10%
Injection site swelling
9%
Diarrhea
6%
Dyspepsia
6%
Neutropenia
5%
Injection site haemorrhage
5%
Decreased Appetite
5%
Dizziness
5%
Insomnia
2%
Febria Neutropenia
1%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
APF530 + Fosaprepitant + Dexamethasone
Ondansetron + Fosaprepitant + Dexamethasone

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Investigational InterventionExperimental Treatment1 Intervention
Fosaprepitant
Group II: Standard-of-Care InterventionActive Control1 Intervention
Metoclopramide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fosaprepitant
2014
Completed Phase 3
~1780

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
458 Previous Clinical Trials
588,649 Total Patients Enrolled
2 Trials studying Nausea
539 Patients Enrolled for Nausea
Benjamin Friedman, MDPrincipal InvestigatorMontefiore Medical Center
8 Previous Clinical Trials
2,062 Total Patients Enrolled
~141 spots leftby Mar 2026