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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
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.
Select...
I have not vomited in the last 24 hours.

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
609 Previous Clinical Trials
1,559,219 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is the trial recruiting?

"Affirmative, according to the clinicaltrials.gov database this trial is actively seeking volunteers. The study was first opened for recruitment on May 14th 2020 and last updated in June 7th 2022. They are aiming to enroll 90 people from a single site."

Answered by AI

Is Arm 1 of the experiment posing any endangerment to participants?

"Arm 1 was determined to be safe and scored a 3 due to being in Phase 4, signifying its official approval."

Answered by AI

Are there still opportunities for participants to join this experiment?

"According to the information found on clinicaltrials.gov, this medical research is currently recruiting for participants. This trial was published online in May of 2020 and last edited in June of 2022."

Answered by AI

What medical condition is Arm 1 of this clinical trial most commonly utilized to manage?

"Arm 1 has a broad range of applications, including treatment of ophthalmia sympathetic and communicable diseases. It is also used to address branch retinal vein occlusion and macular edema."

Answered by AI

Is there an age threshold for recruitment into this investigative undertaking?

"Applicants aged 18-75 are the only ones eligible to join this trial. Those under 18 have access to 99 separate trials while those over 65 can choose from 571 different studies."

Answered by AI

What criteria must patients fulfill to be admitted into this clinical research?

"This clinical trial is enrolling 90 individuals aged 18 to 75 who experience vomiting. Additionally, all participants must meet the following prerequisites: no episodes of vomiting within 24 hours before registration; not being treated with antipsychotics such as risperidone, quetiapine or butyrophenone for 30 days prior to enrollment and during treatment; no known allergies towards granisetron."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Karen Sweiss 2020. "BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04150614.
~0 spots leftby May 2024
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