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

Phase 4

• Conditions: Target Drug-related Adverse Events
• Interventions: 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

• Registration Number: NCT02625155
• Lead Sponsor: InSource Diagnostics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-25
• Study Start: 2015-12
• Study First Submitted QC: 2015-12-08
• Study First Posted: 2015-12-09
• Status Verified: 2017-03
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-02-28
• Primary Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care (SOC Arm)	Urine diagnostic testing as SOC, drug regimen changes per SOC	Standard of Care UDT
Selective PGx Testing (Test Arm)	Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results	Standard of Care UDT with selective PGx testing

Primary Outcome Measures

Name	Time	Method
The proportion of subjects who experience target drug-related adverse events (TDRAE) over the 90-day period following enrollment	90 days

Secondary Outcome Measures

Name	Time	Method
Supra-therapeutic response, as determined by the Investigator	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
Severe TDRAE, defined as a TDRAE that meets the criteria for a Serious Adverse Event	90 days
All TDRAE as quantified within each of the four classes of medications	90 days
TDRAE driving a change in the subject's drug regimen (dose change, discontinuation, substation, or addition of a new drug)	90 days
Ineffective therapeutic response, determined by the Investigator	90 days
Frequency of subjects with changes in drug regimen	90 days

Trial Locations

Locations (1)

Donald H. Deaton, Jr., DO; 🇺🇸 Tazewell, Tennessee, United States