Recruiting

Urine Testing

Sponsor:

InSource Diagnostics

Code:

NCT02625155

Conditions

Target Drug-related Adverse Events

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Interventions

Urine diagnostic testing as SOC, drug regimen changes per SOC

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

Study Details

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

Study ID

NCT02625155

Start date

Dec, 2015

Status verified date

Mar, 2017

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

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

Enrollment

14000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Standard of Care (SOC Arm)

Standard of Care UDT

other: Selective PGx Testing (Test Arm)

Standard of Care UDT with selective PGx testing

Interventions

Urine diagnostic testing as SOC, drug regimen changes per SOC

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

Primary outcome measure

  • The proportion of subjects who experience target drug-related adverse events (TDRAE) over the 90-day period following enrollment [ Time Frame: 90 days ]

Central Contacts and Locations

Locations

Donald H. Deaton, Jr., DO

Recruiting

Tazewell, Tennessee, United States, 37879

Contacts

Donald H. Deaton, DO

423-259-8076

Principal Investigator:

Donald H. Deaton, DO

More Information

Sponsor

InSource Diagnostics

Last update posted

Feb 28, 2018

Last verified

Mar, 2017

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by InSource Diagnostics on 2018-02-28.