Aprepitant for Nausea and Vomiting

Overseen By Emily Ajit-Roger, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Must not be taking: CYP3A4, CYP2CP drugs

Disqualifiers: Children, Pregnant, Breastfeeding, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This project is being carried out to study the use of a medication to reduce nausea and vomiting after ear surgery.

Are You a Good Fit for This Trial?

This clinical trial is for individuals undergoing ear surgery who are at risk of post-operative nausea and vomiting. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information.

Inclusion Criteria

I am an adult scheduled for middle ear surgery.

I use hormonal birth control and understand I need an alternative method for a month after surgery due to treatment effects.

Exclusion Criteria

Patients with a history of hypersensitivity reaction to any of the medications used in the study

I do not have severe liver problems (not Child-Pugh class C).

I cannot undergo surgery with general anesthesia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants receive oral aprepitant 80mg or placebo within an hour of induction

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for incidence of nausea and vomiting using the Postoperative Nausea and Vomiting Intensity Scale

48 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aprepitant

Trial Overview

The trial is testing Aprepitant, a medication intended to reduce nausea and vomiting after ear surgery, against a placebo (a substance with no therapeutic effect). Participants will be randomly assigned to receive either Aprepitant or the placebo.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Oral aprepitant 80mg within an hour of induction

Group II: Control Arm Placebo Group 1 Intervention

Placebo capsule within an hour of induction

Who Is Running the Clinical Trial?

Sir Mortimer B. Davis - Jewish General Hospital

Lead Sponsor

Trials

61

Recruited

25,800+