Using Fosaprepitant to Treat Nausea and Vomiting
Antiemetic Fosaprepitant To Remedy Nausea and Vomiting
This study is testing if a new medication called fosaprepitant can help people with nausea and vomiting feel better compared to the usual treatment they receive.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT06382012 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and safety of fosaprepitant, a new antiemetic, compared to the standard treatment with ondansetron for patients experiencing nausea and vomiting. The study is designed as a randomized, double-blind trial, meaning neither the participants nor the researchers know who receives which treatment to ensure unbiased results. Fosaprepitant works by blocking neurokinin-1 (NK-1) receptors in the central nervous system, potentially offering a more effective solution for patients who often seek care in emergency departments. The trial will assess how well fosaprepitant alleviates symptoms and its side effects compared to traditional antiemetics.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who present with nausea and/or vomiting.
Not a fit: Patients who are pregnant, lactating, or have certain heart conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and safer option for patients suffering from nausea and vomiting.
How similar studies have performed: Other studies have shown promising results with neurokinin inhibitors, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults at least 18 years old * Present to an emergency department (ED) for nausea and/or vomiting as defined by the International Classification of Diseases (ICD-10), or identified by treating clinician * Following the approval of a protocol amendment, study patients who have received an antiemetic and remain persistently nauseated after 2 hours will be eligible to participate in the study Exclusion Criteria: * Pregnancy, desiring pregnancy, or lactating * Antiemetic medication use less than 2 hours prior to screening * Bradycardia (heart rate less than 60 bpm heart rate) * Prolonged QTc (\>480ms) * Not conversant in English or Spanish * Altered mental status * Dementia * Lack of phone for follow-up communication
Where this trial is running
The Bronx, New York
- Montefiore Medical Center (Montefiore and Weiler EDs) — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Benjamin W Friedman, MD MS — Montefiore Medical Center
- Study coordinator: Mustfa K Manzur, MD MPH MS
- Email: mmanzur@montefiore.org
- Phone: 718-920-6626
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.