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PGx-Guided Drug Regimen for Preventing Medication Side Effects (SPHERE Trial)

Phase 4

Waitlist Available

Research Sponsored by InSource Diagnostics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is 12 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

SPHERE Trial Summary

This trial will test whether adding a genetic test to standard drug screening can help reduce harmful side effects from medications.

Who is the study for?

This trial is for individuals aged 12 or older who have experienced adverse drug reactions or are new patients to a healthcare provider's practice. They must be taking or considering treatment with certain drugs like Amitriptyline and Oxycodone, and scheduled for standard urine testing. Those with mandatory PGx testing, in long-term care, on dialysis, with prior PGx tests for the study drugs, or unable to provide accurate medical history cannot join.Check my eligibility

What is being tested?

The study aims to see if using selective pharmacogenomic (PGx) testing based on urine drug tests can reduce bad reactions from target drugs compared to usual care. It will change drug regimens based on PGx results versus standard practices after these urine tests.See study design

What are the potential side effects?

While not directly related to side effects of medications being tested, this trial monitors adverse events caused by current treatments that may include ineffective response or other negative symptoms due to genetic differences affecting drug metabolism.

SPHERE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 12 years old or older.

SPHERE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

All TDRAE as quantified within each of the four classes of medications

Frequency of subjects with changes in drug regimen

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

+4 more

SPHERE Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of Care (SOC Arm)Experimental Treatment1 Intervention

Standard of Care UDT

Group II: Selective PGx Testing (Test Arm)Experimental Treatment1 Intervention

Standard of Care UDT with selective PGx testing

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

InSource DiagnosticsLead Sponsor

SyntactxNETWORK

22 Previous Clinical Trials

1,133,439 Total Patients Enrolled

Media Library

Urine Diagnostic Testing as SOC Clinical Trial Eligibility Overview. Trial Name: NCT02625155 — Phase 4

Adverse Events Research Study Groups: Standard of Care (SOC Arm), Selective PGx Testing (Test Arm)

Adverse Events Clinical Trial 2023: Urine Diagnostic Testing as SOC Highlights & Side Effects. Trial Name: NCT02625155 — Phase 4

Urine Diagnostic Testing as SOC 2023 Treatment Timeline for Medical Study. Trial Name: NCT02625155 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new recruits being admitted to this experiment?

"Clinicaltrials.gov information shows that, as of the last update on February 27th 2018, this clinical trial is not seeking participants at present. However, there are 1 other studies currently open to patient enrolment."

Answered by AI