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

NCT02625155 | Unknown Phase 4

• 1 other identifier: 2017-001
• Study Type: interventional
• Target: 14,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Target Drug-related Adverse Events

Keywords

Pharmacogenomics; Urine Drug Testing; antidepressants; benzodiazepines; opioids; muscle relaxants; non-steroidal anti-inflammatory agents; TDRAE

Outcome Measures

Primary Outcomes (1)

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

  90 days

Secondary Outcomes (7)

• 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

• 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

• Supra-therapeutic response, as determined by the Investigator

  90 days

Study Arms (2)

Standard of Care (SOC Arm)

OTHER

Standard of Care UDT

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

Selective PGx Testing (Test Arm)

OTHER

Standard of Care UDT with selective PGx testing

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

Interventions

Urine diagnostic testing as SOC, drug regimen changes per SOC OTHER

Standard of Care (SOC Arm)

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

Selective PGx Testing (Test Arm)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 12 years of age or older;
• Subject or legal representative is able and willing to provide informed consent;
• 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;
• Subject is scheduled for or is planned to be scheduled for UDT, ordered as per the treating healthcare provider's local standard of care;
• 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.

You may not qualify if:

• Prior history of PGx testing for genes specific to any of the target drugs in the past;
• PGx testing is deemed mandatory in the opinion of the treating healthcare provider;
• History of liver or renal transplantation;
• Receiving chronic hemodialysis or peritoneal dialysis;
• Currently hospitalized or in a long-term care facility;
• Participation in another clinical trial that would, in the Investigator's opinion, interfere with the conduct of this study;
• Subject or subject's guardian or advocate is unable to provide an accurate history of the subject's medical history, medications, and symptoms.

Sponsors & Collaborators

• InSource Diagnostics: lead
• Syntactx: collaborator

Study Sites (1)

Donald H. Deaton, Jr., DO

Tazewell, Tennessee, 37879, United States

RECRUITING

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MeSH Terms

Conditions

Muscle Hypotonia

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: December 9, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Last Updated: February 28, 2018

Record last verified: 2017-03

Locations

US (1)