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

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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.


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
?
mi
from
Tazewell, TN
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