Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 11/24/2016 |
Start Date: | December 2015 |
Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens: SPHERE
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.
(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.
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 is a new patient to the treating physician's practice or has had a TDRAE
within the last 60 days.
4. Subject is currently receiving or the subject's treating physician is considering
treatment with at least one target drug, defined as a medication that falls within
one of the following classes of medications and metabolized by a cytochrome P450
pathway:
- Antidepressants
- Benzodiazepines
- Opioids
- Muscle relaxants; or
- Non-steroidal anti-inflammatory agents.
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.
We found this trial at
1
site
Tazewell, Tennessee 37879
Principal Investigator: Donald H. Deaton, DO
Phone: 423-259-8076
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