Tazewell, Tennessee 37879


Purpose:

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.


Criteria:

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.


NCT ID:

NCT02625155


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Tazewell, Tennessee 37879
United States

Donald H. Deaton, DO
Phone: 423-259-8076

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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