Aprepitant for Nausea and Vomiting

EA
Overseen ByEmily Ajit-Roger, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the medication aprepitant can reduce nausea and vomiting after ear surgery. Participants will receive either aprepitant or a placebo (a pill with no active medicine) before their surgery to assess which is more effective. This trial is ideal for adults scheduled for specific ear surgeries, such as tympanoplasty or stapedectomy. Those relying on hormonal birth control should note that aprepitant might reduce its effectiveness, so additional contraception is recommended for a month after surgery. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

If you are taking medications that affect certain liver enzymes (CYP3A4 or CYP2CP), you may need to stop them because they could interact with the study medication. It's best to discuss your current medications with the study team to see if any changes are needed.

What is the safety track record for this treatment?

Research has shown that aprepitant is generally safe for use. Studies have demonstrated its effectiveness in reducing nausea and vomiting, particularly in cancer patients undergoing chemotherapy. For example, one study found that aprepitant controlled vomiting in 83.33% of patients, compared to only 45.83% of those who did not take the drug. This suggests that aprepitant is both effective and well-tolerated.

Regarding safety, another study examined how adult patients with chemotherapy-related nausea responded to aprepitant. The study confirmed that patients tolerated it well, with no major side effects reported.

Overall, the use of aprepitant in various medical conditions and its positive results in clinical studies suggest it is a safe option for managing nausea and vomiting.12345

Why are researchers enthusiastic about this study treatment?

Aprepitant is unique because it targets the neurokinin-1 (NK1) receptor, which plays a key role in the body's nausea and vomiting pathway. Unlike standard treatments like ondansetron or metoclopramide, which primarily target serotonin receptors, aprepitant offers a different mechanism of action. This makes it particularly exciting for researchers, as it could provide relief for patients who do not respond well to existing medications, potentially offering a new option for managing nausea and vomiting.

What evidence suggests that aprepitant might be an effective treatment for nausea and vomiting after ear surgery?

Research has shown that aprepitant helps reduce nausea and vomiting. In this trial, participants in the treatment arm will receive 80 mg of aprepitant. Previous studies have demonstrated that this dosage significantly reduces vomiting after surgery more than it reduces nausea. Another study found it very effective in preventing nausea and vomiting caused by chemotherapy. Aprepitant also reduces the need for additional anti-nausea medications and improves overall treatment success. This medication has proven effective and is already used to prevent these symptoms in other situations.26789

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.
See 5 more

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?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment ArmExperimental Treatment1 Intervention
Group II: Control ArmPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sir Mortimer B. Davis - Jewish General Hospital

Lead Sponsor

Trials
61
Recruited
25,800+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38013306/

Efficacy and safety of Aprepitant-containing triple therapy ...

Conclusions: Aprepitant-containing triple therapy is highly effective in the prevention and treatment of CINV, with reliable medication safety.

Effect of Aprepitant for the Prevention of Chemotherapy ...

Adding aprepitant to palonosetron and dexamethasone was effective in reducing nausea and vomiting for women who received moderately emetogenic chemotherapy.

The efficacy of aprepitant for the prevention of... : Medicine

Findings showed that administration of 80 mg aprepitant reduced postoperative vomiting significantly more than postoperative nausea (OR: 8.6; 95 ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37478247/

The efficacy of aprepitant for the prevention ...

Further, administration of 80 mg aprepitant was better at preventing vomiting than nausea (OR: 8.6; 95% CI: 3.84, 19. 29; P < .00001). No ...

Aprepitant and fosaprepitant as a prophylactic antiemetic ...

Aprepitant reduces the incidence of postoperative nausea, vomiting and the use of rescue antiemetics and increases the complete response rate among adult ...

Aprepitant - StatPearls - NCBI Bookshelf - NIH

Aprepitant and fosaprepitant are drugs used to prevent nausea and vomiting in cancer patients. Aprepitant can be taken orally or intravenously ( ...

A study on the efficacy and safety of aprepitant injection ...

The effective control rate of acute-phase vomiting in the treatment group was 83.33%, significantly higher than 45.83% in the control group, ...

The Efficacy of Aprepitant

A randomized, double-blind comparison of the NK1 antagonist, aprepitant, versus ondansetron for the prevention of postoperative nausea and vomiting.

Assessment of efficacy, safety, and tolerability of aprepitant ...

The present study was undertaken to assess efficacy, safety, and tolerability of Aprepitant in adult patients with chemotherapy induced nausea ...