Fosaprepitant vs Metoclopramide for Nausea and Vomiting

(BARF RCT Trial)

Not yet recruiting at 1 trial location

Overseen By Mustfa K Manzur, MD MPH MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Montefiore Medical Center

Must not be taking: Antiemetics

Disqualifiers: Pregnancy, Bradycardia, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 2 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares the effectiveness of fosaprepitant and metoclopramide in treating nausea and vomiting. Researchers aim to determine which drug is more effective and has fewer side effects. Fosaprepitant, a newer treatment, acts on the brain to prevent vomiting. This trial may suit adults visiting the emergency room for nausea or vomiting who have not taken anti-nausea medication beforehand. As a Phase 4 trial, this research helps clarify how the FDA-approved treatment benefits a broader range of patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have used antiemetics (medications to prevent nausea and vomiting) or received intravenous fluids before coming to the emergency department, you would not be eligible to participate.

What is the safety track record for these treatments?

Studies have shown that fosaprepitant is generally safe and well-tolerated. Once converted in the body to its active form, aprepitant, it effectively prevents nausea and vomiting. Some studies reported that it is well-tolerated over several days of use, with no deaths noted.

The FDA has already approved fosaprepitant for preventing nausea and vomiting caused by chemotherapy and surgery, indicating a strong safety record for these uses. While all treatments can have side effects, fosaprepitant has been studied for over a decade and is considered to have a manageable safety profile.

In comparison, metoclopramide, the standard treatment in the trial, is also widely used and well-understood. Both options have undergone extensive testing, but fosaprepitant could offer a new choice for those seeking alternative treatments for nausea and vomiting. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Fosaprepitant is unique because it targets nausea and vomiting differently than traditional options like metoclopramide. While metoclopramide works by blocking dopamine receptors in the brain, fosaprepitant tackles the issue by blocking neurokinin-1 (NK1) receptors, which are involved in the vomiting reflex. This new mechanism of action can potentially offer better control of symptoms, especially for those who haven't found relief with existing treatments. Researchers are excited about fosaprepitant because it could provide a more effective alternative for patients suffering from nausea and vomiting.

What evidence suggests that this trial's treatments could be effective for nausea and vomiting?

In this trial, participants will receive either fosaprepitant or metoclopramide to treat nausea and vomiting. Research has shown that fosaprepitant, a medication that blocks signals in the brain causing vomiting, is highly effective for treating nausea and vomiting, particularly after surgery or during chemotherapy. One study found that 76.2% of people taking aprepitant (the active form of fosaprepitant) did not experience vomiting, compared to 62.1% of those receiving standard treatments. Another study demonstrated that fosaprepitant effectively reduced nausea and vomiting soon after surgery. This medication is generally well-tolerated and acts quickly. These findings suggest it could be a strong option for treating nausea and vomiting in emergency situations. ^{1 6 7 8 9}

Who Is on the Research Team?

Benjamin W Friedman, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who come to the emergency department with nausea and/or vomiting. They must be able to speak English or Spanish, have a phone for follow-up, and not be pregnant, lactating, or wanting pregnancy. Excluded are those with recent antiemetic use, bradycardia, prolonged QTc on ECG, altered mental status or dementia.

Inclusion Criteria

I went to the emergency department for nausea or vomiting.

Exclusion Criteria

Pregnancy, desiring pregnancy, or lactating

Bradycardia (< 60 bpm heart rate)

Prolonged QTc (greater than 490ms)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either fosaprepitant or metoclopramide to assess efficacy and adverse event profile

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for sustained relief from nausea and vomiting and development of new symptoms

24 hours

Follow-up assessments at 2 hours and 24 hours

What Are the Treatments Tested in This Trial?

Interventions

• Fosaprepitant
• Metoclopramide

Trial Overview The study compares fosaprepitant's effectiveness against metoclopramide in treating nausea and vomiting. It's a double-blind RCT where neither doctors nor patients know who gets which drug. Fosaprepitant acts on the brain to block signals that cause vomiting and could be cheaper than current treatments.

How Is the Trial Designed?

Group I: Investigational Intervention Experimental Treatment 1 Intervention

Fosaprepitant

Group II: Standard-of-Care Intervention Active Control 1 Intervention

Metoclopramide

Fosaprepitant is already approved in United States, European Union for the following indications:

Approved in United States as Emend for:

• Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy
• Prevention of delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy

Approved in European Union as Emend for:

• Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy
• Prevention of delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Published Research Related to This Trial

Fosaprepitant, a neurokinin-1 receptor antagonist, is effective and safe for preventing chemotherapy-induced nausea and vomiting (CINV) in cancer patients undergoing highly emetogenic chemotherapy, offering a promising alternative to traditional antiemetic therapies.

As an intravenous formulation, fosaprepitant overcomes the limitations of oral aprepitant, potentially improving patient compliance and quality of life during chemotherapy treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical research study for fosaprepitant to prevent chemotherapy-induced nausea and vomiting: A review. Xue, F., Liu, X., Qi, X., et al.[2023]

Fosaprepitant is an effective antiemetic used primarily for patients undergoing moderately to highly emetogenic chemotherapy, but it can cause local injection site reactions, which are the most common infusion-related issues.

This report highlights two cases of systemic hypersensitivity reactions to fosaprepitant infusions, suggesting that while generally safe, there may be rare but serious allergic responses that healthcare providers should monitor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic hypersensitivity to fosaprepitant - A report of two cases. Baxley, A., Lee, Z., Medina, P.[2018]

A practice change to dilute fosaprepitant to 150 mg/250 ml and infuse it over 30 minutes significantly reduced the incidence of infusion-site reactions from 28.7% to 5.74% in cancer patients receiving the medication.

This study, which reviewed the medical records of 122 patients, suggests that the new administration method improves patient tolerance and should be considered by oncology pharmacists for better safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updated report on incidence of infusion-site reactions associated with peripheral intravenous administration of fosaprepitant. Chau, E., Lundberg, J., Phillips, G., et al.[2019]

Intravenous fosaprepitant is an effective antiemetic for preventing nausea and vomiting in adult cancer patients undergoing highly and moderately emetogenic chemotherapy, showing good efficacy in large phase III trials with a single 150 mg dose.

Fosaprepitant is well tolerated and has a safety profile similar to that of oral aprepitant, making it a valuable addition to standard antiemetic regimens that include dexamethasone and serotonin 5-HT3 receptor antagonists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fosaprepitant Dimeglumine: A Review in the Prevention of Nausea and Vomiting Associated with Chemotherapy. Garnock-Jones, KP.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4391760/

Aprepitant and Fosaprepitant: A 10-Year Review of Efficacy ... Significantly more aprepitant recipients than controls achieved no vomiting (76.2% vs. 62.1%; p < .001) and complete response (68.7% vs. 56.3%; p < .001) in the ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2768276525000185

Fosaprepitant Use as an Antiemetic to Prevent ... Fosaprepitant is an effective agent to treat postoperative nausea and vomiting in adults, but has not been extensively studied in pediatrics for this purpose.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06382012

Antiemetic Fosaprepitant To Remedy Nausea and Vomiting The primary outcome for the tolerability analysis will be the development of any new symptom within 2 hours of medication administration.

4. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-13469-6

a complement to fosaprepitant in the prevention ... - BMC Cancer The CR rate for vomiting and nausea in the acute phase is 77.32% and 97.4% respectively, increasing over time. 23.48% or 3.10% of patients ...

5. link.springer.com link.springer.com/article/10.1007/s44254-024-00075-1

Efficacy of fosaprepitant for the prevention of postoperative ... These results suggest that fosaprepitant may be beneficial in suppressing early stage postoperative nausea. There was no significant difference ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2023/216686Orig1s000MultidisciplineR.pdf

center for drug evaluation and research - accessdata.fda.gov A study to evaluate pharmacokinetics, safety, and tolerability of a single dose of. Fosaprepitant Injection 150 mg/50 mL (3 mg/mL) for ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04054193

Safety of a Three-Day Fosaprepitant Regimen for the ... The purpose of this study is to evaluate the safety and tolerability of a 3-day intravenous (IV) fosaprepitant dimeglumine (MK-0517) regimen for the ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/08880018.2024.2437047

Safety and Tolerability of a 3-Day Fosaprepitant Regimen ... Similar trends in safety outcomes were observed during cycles 2 and 3. No deaths were reported. The 3-day IV fosaprepitant regimen for the prevention of CINV ...

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.2017.35.31_suppl.93

Pharmacokinetics/pharmacodynamics (PK/PD), safety, and ... Fosaprepitant is approved to prevent CINV in adults. The aim of this study was to determine appropriate fosaprepitant dosing in children.