Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens (SPHERE)

InSource Diagnostics

Status and phase: Unknown; Phase 4

Conditions: Target Drug-related Adverse Events

Treatments: Other: Urine diagnostic testing as SOC, drug regimen changes per SOC; Other: Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT02625155

2017-001

Details and patient eligibility

About

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.

Enrollment: 14,000 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14,000 participants in 2 patient groups

Standard of Care (SOC Arm)

Other group

Description:

Standard of Care UDT

Treatment:

Other: Urine diagnostic testing as SOC, drug regimen changes per SOC

Selective PGx Testing (Test Arm)

Other group

Description:

Standard of Care UDT with selective PGx testing

Treatment:

Other: Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results