Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice:

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06322238
Phase
PHASE2
Status
Recruiting
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Conditions

  • Drug Metabolism, Poor, CYP2C19-Related
  • Drug Metabolism, Poor, CYP2D6-Related
  • Ineffective Drug Action
  • Pharmacogenomic Drug Interaction
  • Side Effect of Drug

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • PGx panel test — DIAGNOSTIC_TEST
    In this prospective, non-randomized, step-wedge design controlled clinical study (PREPARE-MAYO Rochester, Mayo Clinic Health System), pre-emptive genotyping of a panel of clinically relevant PGx-markers, for which CPIC guidelines are available.

Study Details

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').

Key Dates

Start date
Dec 1, 2024
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
66 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: PGx testing arm
  • Placebo Comparator: Delayed PGx testing arm

Primary Outcome Measure

Adverse Drug Reaction (ADR) [ Time Frame: 48 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55902
Elisa Houwink, MD, PhD
[email protected]
5073192037
Mary Johnson
[email protected]
Jessica Wright, PharmD (SUB_INVESTIGATOR)

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