Nausea: a review of pathophysiology and therapeutics.
Prashant Singh, Sonia S Yoon, Braden Kuo
https://pubmed.ncbi.nlm.nih.gov/26770271Actively Recruiting
Phase 2
Phase 3
Age: 18Years +
All Genders
ID06382012
Antiemetic Fosaprepitant To Remedy Nausea and Vomiting
Led by Montefiore Medical Center · Updated on 2026-05-18
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Brief Title
Antiemetic Fosaprepitant To Remedy Nausea and Vomiting
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults at least 18 years old
- Presenting to an emergency department for nausea and/or vomiting as defined by ICD-10 or identified by a treating clinician
- Patients who have received an antiemetic and remain nauseated after 2 hours following protocol amendment approval
You will not qualify if you...
- Pregnancy, desiring pregnancy, or lactating
- Use of antiemetic medication within 2 hours prior to screening
- Bradycardia with heart rate less than 60 beats per minute
- Prolonged QTc interval greater than 480 milliseconds
- Not conversant in English or Spanish
- Altered mental status
- Dementia
- Lack of phone for follow-up communication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 2 hours
Participants receive a single dose of either Fosaprepitant or Ondansetron intravenously to treat nausea and vomiting.
1 treatment visit (in-person)
Follow-up
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)
Trial Site Locations
Total: 1 location
1
Montefiore Medical Center (Montefiore and Weiler EDs)
The Bronx, New York, United States, 10467
Actively Recruiting
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Research Team
M
Mustfa K Manzur, MD MPH MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Matti Aapro, Alexandra Carides, Bernardo L Rapoport...
https://pubmed.ncbi.nlm.nih.gov/25795636Fosaprepitant and aprepitant: an update of the evidence for their place in the prevention of chemotherapy-induced nausea and vomiting.
Patrick Langford, Paul Chrisp
https://pubmed.ncbi.nlm.nih.gov/21042544Drugs for the treatment of nausea and vomiting in adults in the emergency department setting.
Jeremy S Furyk, Robert A Meek, Diana Egerton-Warburton
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Yunpeng Yang, Nong Yang, Lin Wu...
https://pubmed.ncbi.nlm.nih.gov/33161724Cost-effectiveness of ondansetron for postoperative nausea and vomiting.
M R Tramèr, C Phillips, D J Reynolds...
https://pubmed.ncbi.nlm.nih.gov/10364857