Recruiting PHASE2, PHASE3 Nausea and Vomiting

New treatment option for Nausea and Vomiting

Official title Antiemetic Fosaprepitant To Remedy Nausea and Vomiting

ClinicalTrials.gov ID: NCT06382012

What this study is testing

What is Fosaprepitant 150 mg?

Fosaprepitant 150 mg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nausea and vomiting.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The study team proposes a randomized, double-blind, RCT to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic ondansetron. 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.
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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...
  • Following the approval of a protocol amendment, study patients who have received an antiemetic and remain persistently nauseated after 2 hours will...

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • The Bronx, New York, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.