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

February 27, 2018 updated by: InSource Diagnostics

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

14000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Tazewell, Tennessee, United States, 37879
        • Recruiting
        • Donald H. Deaton, Jr., DO
        • Contact:
          • Donald H. Deaton, DO
          • Phone Number: 423-259-8076
        • Principal Investigator:
          • Donald H. Deaton, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InSource Diagnostics

Collaborators

Syntactx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 25, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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