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5-HT3 Receptor Antagonist

Granisetron Patch vs Ondansetron for Nausea and Vomiting

Phase 4
Recruiting
Led By Karen Sweiss, PharmD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-75 years at time of enrollment receiving either a preparative regimen and either an autologous or allogeneic stem cell transplant.
No vomiting ≤ 24 hours prior to registration
Must not have
Patients with a history of long QT syndrome or Torsade de Pointes
Concurrent use of amifostine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is more effective at reducing CINV in patients undergoing an HSCT than the current standard of care.

Who is the study for?
This trial is for adults aged 18-75 undergoing stem cell transplant and chemotherapy, who haven't vomited in the last 24 hours or taken certain antipsychotic drugs recently. It's not for those allergic to granisetron or ondansetron, with a history of specific heart rhythm problems, or using amifostine.Check my eligibility
What is being tested?
The study compares two anti-nausea treatments in patients receiving stem cell transplants: a granisetron patch versus ondansetron. The goal is to see which one better prevents nausea and vomiting caused by chemotherapy.See study design
What are the potential side effects?
Possible side effects include skin reactions at the patch site for granisetron, headaches, constipation, and potential heart rhythm changes. Ondansetron can cause headaches, dizziness, constipation as well as rare heart-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old and will receive a stem cell transplant.
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I have not vomited in the last 24 hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of long QT syndrome or Torsade de Pointes.
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I am currently taking amifostine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy/Safety of Transdermal Granisetron for Prevention of CINV
Secondary outcome measures
Efficacy/Safety of Ondansetron and Transdermal Granisetron for Prevention of CINV
Efficacy/Safety of Ondansetron for Prevention of CINV

Trial Design

2Treatment groups
Active Control
Group I: Arm 1Active Control2 Interventions
ARM 1 -transdermal granisetron plus intravenous dexamethasone
Group II: ARM 2Active Control2 Interventions
ARM 2 -intravenous ondansetron plus intravenous dexamethasone

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
618 Previous Clinical Trials
1,563,734 Total Patients Enrolled
Karen Sweiss, PharmD3.520 ReviewsPrincipal Investigator - University of Illinois at Chicago
University of Illinois at Chicago
1Patient Review
The long wait time for an appointment was only the beginning of my issues with Dr. Sweiss. I waited almost two hours for her to show up to the office, which her own staff says is typical. This is completely unacceptable. Her disorganization and lack of readiness for my appointment led to accomplishing absolutely nothing. She ordered a test which has already been done and then had the resident let me know that she wanted to follow up in 3 to 6 months. I'm not sure what the follow up was for since she did absolutely nothing during this appointment time. The incompetence, lack of professionalism, and lack of compassion shown by UI

Media Library

Granisetron Transdermal Patch (5-HT3 Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04150614 — Phase 4
Nausea and Vomiting Research Study Groups: Arm 1, ARM 2
Nausea and Vomiting Clinical Trial 2023: Granisetron Transdermal Patch Highlights & Side Effects. Trial Name: NCT04150614 — Phase 4
Granisetron Transdermal Patch (5-HT3 Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04150614 — Phase 4
~18 spots leftby Jun 2025
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