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Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens

NCT02625155 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14000

Last updated 2018-02-28

No results posted yet for this study

Summary

The purpose of this study is to determine whether the addition of selective pharmacogenomic (PGx) testing as determined by Urine Drug Testing (UDT) adds a clinical benefit as evidenced by a reduction in Target Drug-related Adverse Events (TDRAE) over the period following enrollment.

Conditions

  • Target Drug-related Adverse Events

Interventions

OTHER

Urine diagnostic testing as SOC, drug regimen changes per SOC

OTHER

Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results

Sponsors & Collaborators

  • Syntactx

    collaborator NETWORK

  • InSource Diagnostics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-12-31

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 NCT02625155 on ClinicalTrials.gov