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

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ClinicalTrials.gov Identifier: NCT02625155
Recruitment Status : Unknown
Verified March 2017 by InSource Diagnostics.
Recruitment status was:  Recruiting
First Posted : December 9, 2015
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
Syntactx
Information provided by (Responsible Party):
InSource Diagnostics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Target Drug-related Adverse Events 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 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens: SPHERE
Study Start Date : December 2015
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Standard of Care (SOC Arm)
Standard of Care UDT
 Other: Urine diagnostic testing as SOC, drug regimen changes per SOC
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


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

Secondary Outcome Measures :
  1. All TDRAE as quantified within each of the four classes of medications [ Time Frame: 90 days ]
  2. TDRAE driving a change in the subject's drug regimen (dose change, discontinuation, substation, or addition of a new drug) [ Time Frame: 90 days ]
  3. Severe TDRAE, defined as a TDRAE that meets the criteria for a Serious Adverse Event [ Time Frame: 90 days ]
  4. Ineffective therapeutic response, determined by the Investigator [ Time Frame: 90 days ]
  5. Supra-therapeutic response, as determined by the Investigator [ Time Frame: 90 days ]
  6. Frequency of subjects with changes in drug regimen [ Time Frame: 90 days ]
  7. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625155


Locations
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United States, Tennessee
Donald H. Deaton, Jr., DO Recruiting
Tazewell, Tennessee, United States, 37879
Contact: Donald H. Deaton, DO    423-259-8076      
Principal Investigator: Donald H. Deaton, DO         
Sponsors and Collaborators
InSource Diagnostics
Syntactx
More Information
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Publications:
Local Coverage Determination (LCD): CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing (L35472). 2015. (Accessed 8/10/2015, at https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35472&ContrId=357.)
Disability Evaluation Under Social Security. (Accessed 3/5/2014, 2014, at http://www.ssa.gov/disability/professionals/bluebook/general-info.htm.)
Inter-agency guideline for opioid dosing for chronic non-cancer pain.2010.
National Bioeconomy Blueprint. The White House; 2012:48.
World Guide for Drug Use and Pharmacogenomics. Corunna, Spain: EuroEspes Publishing; 2012.
Model policy on the use of opioid analgesics in the treatment of chronic pain. Federation of State Medical Boards; 2013.
ACOEM. Guidelines for the Chronic Use of Opioids. 2 ed: American College of Occupational and Environmental Medicine.

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Responsible Party: InSource Diagnostics
ClinicalTrials.gov Identifier: NCT02625155    
Other Study ID Numbers: 2017-001
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: March 2017
Keywords provided by InSource Diagnostics:
Pharmacogenomics
Urine Drug Testing
antidepressants
benzodiazepines
 opioids
muscle relaxants
non-steroidal anti-inflammatory agents
TDRAE