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Drug & Gene Interaction Risk Analysis With & Without Genetic Testing Among Patients Undergoing MTM

NCT02428660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 341

Last updated 2017-02-23

No results posted yet for this study

Summary

This randomized controlled trial will evaluate whether the use of pharmacogenetic testing through a Medication Therapy Management (MTM) program has a beneficial impact on drug therapy problems. More specifically, cytochrome DNA testing, which provides information with regards to participant specific metabolism of medications, will be used in the evaluation of participant medication regimens. The overall aim of the project is to evaluate if the addition of genetic CYP testing to a standardized MTM Program provides increased clinical value. To answer this question, the investigators will look at the drug therapy problems (DTPs) identified by the genetic test compared to those DTPs discovered without the test.

Conditions

  • Cytochrome P450 CYP2D6 Enzyme Deficiency
  • Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant
  • Ultrarapid Metabolizer Due to Cytochrome P450 CYP2D6 Variant
  • Extensive Metabolizer Due to Cytochrome P450 CYP2D6 Variant
  • Cytochrome P450 CYP2C9 Enzyme Deficiency
  • Cytochrome P450 CYP2C19 Enzyme Deficiency
  • Drug Metabolism, Poor, CYP2D6-RELATED
  • Drug Metabolism, Poor, CYP2C19-RELATED
  • CYP2D6 Polymorphism

Interventions

GENETIC

Pharmacogenetic testing

Genetic testing for 2D6, 2C9, 2C19, 3A4, 3A5 polymorphisms

OTHER

Software-based drug & gene interaction risk analysis

By assessing a patient's medication list along with the frequencies of variant phenotypes in the population, YouScript is able to identify whether a patient might be at risk for an adverse drug event and suggest when testing might be appropriate.

OTHER

MTM

Medication Therapy Management

Sponsors & Collaborators

  • Genelex Corporation

    lead INDUSTRY

Principal Investigators

  • Jonathan W Magness, PharmD · VRx Pharmacy Services

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02428660 on ClinicalTrials.gov