Drugs for the treatment of nausea and vomiting in adults in the emergency department setting.
Jeremy S Furyk, Robert A Meek, Diana Egerton-Warburton
https://pubmed.ncbi.nlm.nih.gov/26411330/Actively Recruiting
Led by Montefiore Medical Center · Updated on 2026-05-18
200
Participants Needed
1
Research Sites
N/A
Total Duration
Nausea and vomiting NV are common conditions affecting millions of adults each year, leading many to seek emergency department ED care. Researchers are evaluating fosaprepitant, a newer antiemetic drug that blocks neurokinin NK-1 in the brain, to compare its effectiveness and side effects against the standard antiemetic ondansetron. Fosaprepitant is currently approved only for chemotherapy-induced and postoperative NV, and this study aims to determine if it may better serve patients with NV in the ED setting. Participants will be randomly assigned to receive either fosaprepitant 150 mg or ondansetron 4 mg, both given intravenously over 15 minutes. This double-blind trial compares these two medications to assess their ability to relieve nausea and vomiting and monitor adverse events within 2 hours after administration. The study includes adults presenting to the ED with NV, some of whom may have previously received antiemetics but remain symptomatic after 2 hours. During the study, participants will be monitored for relief from NV and any new symptoms within 2 hours following medication. Additional assessments include sustained relief at 24 hours, ED length of stay, and patient medication preference for future episodes. Follow-up communication will be conducted by phone. The total study duration allows careful evaluation of treatment efficacy and tolerability while ensuring participant safety and convenience.
CONDITIONS
Antiemetic Fosaprepitant To Remedy Nausea and Vomiting
M
Mustfa K Manzur, MD MPH MS
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Montefiore Medical Center
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Fosaprepitant (investigational arm) | Ondansetron (active comparator arm) |
|---|---|---|
| What is it? | Fosaprepitant is an intravenous neurokinin-1 (NK1) receptor antagonist being evaluated for the acute treatment of nausea and vomiting during emergency department visits. | Ondansetron is an intravenous 5-HT3 receptor antagonist commonly used as an antiemetic for patients with nausea and vomiting in the emergency department. |
| Role in trial | Investigational drug arm; receives fosaprepitant to test whether it offers acute nausea and vomiting relief compared to standard antiemetic care. | Active comparator arm; receives standard-of-care ondansetron for the same symptoms in the same clinical setting. |
| Primary use | Being studied as a treatment for acute nausea and vomiting in adults presenting to the emergency department. | Established treatment for control of acute nausea and vomiting in the emergency department as recommended by guidelines. |
| How is it given or performed? | Fosaprepitant is delivered intravenously over approximately 15 minutes. | Ondansetron is also administered intravenously over about 15 minutes. |
| Evidence status | Fosaprepitant has extensive evidence for preventing nausea and vomiting in chemotherapy and post-operative settings, but its use in acute emergency department cases is investigational and not yet established. | Ondansetron’s effectiveness for emergency department patients with nausea and vomiting is well supported by clinical guidelines and multiple studies. |
| Important limitations | Fosaprepitant is not yet established for emergency department nausea and vomiting, and there is limited evidence outside of chemotherapy and postoperative use. Safety and results for this specific setting are under study. | Although ondansetron is widely used and supported by guidelines, its effectiveness may vary depending on the cause of symptoms, and some patients may not respond to first-line therapy. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 hours
Participants receive a single dose of either Fosaprepitant or Ondansetron intravenously to treat nausea and vomiting.
1 treatment visit (in-person)
Duration - 24 hours
Participants are monitored for treatment effectiveness and any adverse events up to 24 hours after medication administration.
1 follow-up visit (in-person)
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor