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New treatment option for Pharmacogenomic Drug Interaction
Official title Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice:
ClinicalTrials.gov ID: NCT06322238
What this study is testing
- What it's testing
- The purpose of this study is to determine whether the implementation of pre-emptive pharmacogenomic (PGx) testing of a panel of clinically relevant PGx markers, to guide the dose and drug selection for 39 commonly prescribed drugs, will result in an overall reduction in the number of clinically relevant drug-genotype associated ADRs which are causally related to the initial drug of inclusion (referred to as 'index drug').
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Subject must be ≥ 18 years old
- Subject must receive a 1st prescription (meaning no known prescription for this drug in the preceding 12 months) for a drug included in Table 1...
- Subject is able and willing to take part and willing to be followed up on for 48 weeks
- Subject is able to donate saliva
You likely can't join if
- For the investigational arm only: Previous (direct-to-consumer, or clinical) pharmacogenomic testing that includes any of the genes included in the...
- Pregnant or lactating (to be verbally confirmed with the patient)
- Life expectancy estimated to be less than three months as determined by patient receiving hospice care
- Duration of index drug total treatment length is planned to be less than seven consecutive days.
- Current inpatients
- Unable to consent to the study
See the full eligibility criteria
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Subject must be ≥ 18 years old
- Subject must receive a 1st prescription (meaning no known prescription for this drug in the preceding 12 months) for a drug included in Table 1, which is prescribed to them in routine primary care.
- Subject is able and willing to take part and willing to be followed up on for 48 weeks
- Subject is able to donate saliva
- Subject has signed informed consent
- Subject meets requirement for computer access implying computer literacy as measured by active use of the patient portal or their email
- For the investigational arm only: Previous (direct-to-consumer, or clinical) pharmacogenomic testing that includes any of the genes included in the Focused Pharmacogenomics Panel
- Pregnant or lactating (to be verbally confirmed with the patient)
- Life expectancy estimated to be less than three months as determined by patient receiving hospice care
- Duration of index drug total treatment length is planned to be less than seven consecutive days.
- Current inpatients
- Unable to consent to the study
- Unwilling to take part
- Subject has no permanent address
- Subject has no current primary care provider
- Subject is, in the opinion of the study coordinator after discussion with participating clinician/pharmacist/investigator, not suitable to participate in the study
- Patient has a diagnosis of stage 4 or 5 chronic kidney disease (CKD) or is receiving dialysis
- Patients with advanced liver failure (stage Child-Pugh C) or a diagnosis of liver cirrhosis
- History of a liver transplant or an allogeneic hematopoietic stem cell transplant
- DNA sample collected that requires retesting in the event that DNA collected was not sufficient for testing as determined by the laboratory
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.