Your session is about to expire
← Back to Search
Pharmacogenomics and Post-Operative Nausea and Vomiting
Phase 4
Waitlist Available
Led By Yvette N Martin, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-48 hours post bariatric surgery
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
Pivotal Trial
Summary
The Researchers overall goal is to evaluate the benefit and utility of preemptive genotypic data to guide post-operative nausea and vomiting treatment in the bariatric surgical population. The hypothesis is that using genotypic variation in CYP2D6 to select the appropriate 5HT3 serotonin receptor antagonist to treat PONV will decrease rates of PONV in the bariatric surgical population.
Eligible Conditions
- Postoperative Nausea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-48 hours post bariatric surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-48 hours post bariatric surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Episodes of Postoperative Nausea
Episodes of Postoperative Vomiting
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: CYP2D6 rapid metabolizerExperimental Treatment1 Intervention
Participants with CYP2D6 rapid metabolizer status will received granisetron for for post operative nausea and vomiting prophylaxis and treatment
Group II: CYP2D6 normal metabolizerExperimental Treatment1 Intervention
Participants with CYP2D6 poor or normal metabolizer status will received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Granisetron
FDA approved
Ondansetron
FDA approved
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,066,032 Total Patients Enrolled
Yvette N Martin, MD, PhDPrincipal InvestigatorMayo Clinic