Target Drug-related Adverse Events
Conditions
Keywords
Pharmacogenomics, Urine Drug Testing, antidepressants, benzodiazepines, opioids, muscle relaxants, non-steroidal anti-inflammatory agents, TDRAE
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.
Interventions
OTHERUrine diagnostic testing as SOC, drug regimen changes per SOC
OTHERUrine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results
Sponsors
Syntactx
InSource Diagnostics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who experience target drug-related adverse events (TDRAE) over the 90-day period following enrollment | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| TDRAE driving a change in the subject's drug regimen (dose change, discontinuation, substation, or addition of a new drug) | 90 days |
| Severe TDRAE, defined as a TDRAE that meets the criteria for a Serious Adverse Event | 90 days |
| Ineffective therapeutic response, determined by the Investigator | 90 days |
| All TDRAE as quantified within each of the four classes of medications | 90 days |
| Frequency of subjects with changes in drug regimen | 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 | 90 days |
| Supra-therapeutic response, as determined by the Investigator | 90 days |
Countries
United States
Outcome results
None listed