Clinical trial NCT02625155: Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens
Official title: Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens: SPHERE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Target Drug-related Adverse Events
Keywords: Pharmacogenomics
Urine Drug Testing
antidepressants
benzodiazepines
opioids
muscle relaxants
non-steroidal anti-inflammatory agents
TDRAE
Lead sponsor: InSource Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: Syntactx
First posted: 2015-12-09
Enrollment: 14000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility 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.

Primary outcomes:
measure: The proportion of subjects who experience target drug-related adverse events (TDRAE) over the 90-day period following enrollment
timeFrame: 90 days
Secondary outcomes:
measure: All TDRAE as quantified within each of the four classes of medications
timeFrame: 90 days
measure: TDRAE driving a change in the subject's drug regimen (dose change, discontinuation, substation, or addition of a new drug)
timeFrame: 90 days
measure: Severe TDRAE, defined as a TDRAE that meets the criteria for a Serious Adverse Event
timeFrame: 90 days
measure: Ineffective therapeutic response, determined by the Investigator
timeFrame: 90 days
measure: Supra-therapeutic response, as determined by the Investigator
timeFrame: 90 days
measure: Frequency of subjects with changes in drug regimen
timeFrame: 90 days
measure: 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
timeFrame: 90 days
Other outcomes:
Locations:
city: Tazewell
country: United States
facility: Donald H. Deaton, Jr., DO
state: Tennessee
Study officials:
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