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

InSource Diagnostics14,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

14,000

Conditions

Target Drug-related Adverse Events

Interventions

Urine diagnostic testing as SOC, drug regimen changes per SOCOTHER

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

Eligibility

Sex: ALLMin age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject is 12 years of age or older; 2. Subject or legal representative is able and willing to provide informed consent; 3. Subject has had a TDRAE including ineffective therapeutic response within the last 60 days or is a new patient to the treating healthcare provider's practice; 4. Subject is scheduled for or is planned to be scheduled for UDT, ordered as per the treating healthcare provider's local standard of care; 5. Subject is currently receiving or the subject's treating healthcare provider is considering treatment with at least one target drug listed below and metabolized by one or more genes considered in this study: Amitriptyline, Imipramine, Diazepam, Alprazolam, Codeine, Hydrocodone, Oxycodone, Methadone, Meperidine, Fentanyl and Carisoprodol. Exclusion Criteria: 1. Prior history of PGx testing for genes specific to any of the target drugs in the past; 2. PGx testing is deemed mandatory in the opinion of the treating healthcare provider; 3. History of liver or renal transplantation; 4. Receiving chronic hemodialysis or peritoneal dialysis; 5. Currently hospitalized or in a long-term care facility; 6. Participation in another clinical trial that would, in the Investigator's opinion, interfere with the conduct of this study; 7. Subject or subject's guardian or advocate is unable to provide an accurate history of the subject's medical history, medications, and symptoms.

Locations (1)

Donald H. Deaton, Jr., DO

Tazewell, Tennessee, United States

RECRUITING

Outcomes

Primary Outcomes

The proportion of subjects who experience target drug-related adverse events (TDRAE) over the 90-day period following enrollment

Time frame: 90 days

Secondary Outcomes

All TDRAE as quantified within each of the four classes of medications

Time frame: 90 days

TDRAE driving a change in the subject's drug regimen (dose change, discontinuation, substation, or addition of a new drug)

Time frame: 90 days

Severe TDRAE, defined as a TDRAE that meets the criteria for a Serious Adverse Event

Time frame: 90 days

Ineffective therapeutic response, determined by the Investigator

Time frame: 90 days

Supra-therapeutic response, as determined by the Investigator

Time frame: 90 days

Frequency of subjects with changes in drug regimen

Time frame: 90 days

Healthcare resource utilization, as measured by the number of outpatient clinic visits, emergency room/urgent care visits, and hospitalizations; tabulated over the 90-day period following enrollment

Time frame: 90 days

Data from ClinicalTrials.gov

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