Target Drug-related Adverse EventsPhase 4SPHERENCT02625155
Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens
A Phase 4 study testing Urine diagnostic testing as SOC, drug regimen changes per SOC and Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results in people with Target Drug-related Adverse Events, run by InSource Diagnostics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Target Drug-related Adverse Events
- What is being tested?
- Urine diagnostic testing as SOC, drug regimen changes per SOC and Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,000 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Donald H. Deaton, Jr., DO
Tazewell, Tennessee, 37879
Donald H. Deaton, DO, 423-259-8076
Donald H. Deaton, DO
About this study
Official title: 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.
- Conditions
- Target Drug-related Adverse Events
- Being tested
- 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
- Keywords
- Pharmacogenomics, Urine Drug Testing, antidepressants, benzodiazepines, opioids, muscle relaxants, non-steroidal anti-inflammatory agents, TDRAE
- Medical subject headings
- Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine diagnostic testing as SOC, drug regimen changes per SOCOther
Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test resultsOther
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC Arm) | Other | Standard of Care UDT Receives: 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 Receives: Other: Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who experience target drug-related adverse events (TDRAE) over the 90-day period following enrollment
Measured: 90 days
Secondary outcomes (7)
All TDRAE as quantified within each of the four classes of medications
Measured: 90 days
TDRAE driving a change in the subject's drug regimen (dose change, discontinuation, substation, or addition of a new drug)
Measured: 90 days
Severe TDRAE, defined as a TDRAE that meets the criteria for a Serious Adverse Event
Measured: 90 days
Ineffective therapeutic response, determined by the Investigator
Measured: 90 days
Supra-therapeutic response, as determined by the Investigator
Measured: 90 days
Frequency of subjects with changes in drug regimen
Measured: 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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Target Drug-related Adverse EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InSource Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625155
- Sponsor's protocol ID
- 2017-001
- Acronym
- SPHERE
- Status last verified
- Mar 2017
- First submitted
- 25 Nov 2015
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Phimister EG, Feero WG, Guttmacher AE. Realizing genomic medicine. N Engl J Med. 2012 Feb 23;366(8):757-9. doi: 10.1056/NEJMe1200749. No abstract available.
PubMed 22356329Rebsamen MC, Desmeules J, Daali Y, Chiappe A, Diemand A, Rey C, Chabert J, Dayer P, Hochstrasser D, Rossier MF. The AmpliChip CYP450 test: cytochrome P450 2D6 genotype assessment and phenotype prediction. Pharmacogenomics J. 2009 Feb;9(1):34-41. doi: 10.1038/tpj.2008.7. Epub 2008 Jul 1.
PubMed 18591960Hicks JK, Bishop JR, Sangkuhl K, Muller DJ, Ji Y, Leckband SG, Leeder JS, Graham RL, Chiulli DL, LLerena A, Skaar TC, Scott SA, Stingl JC, Klein TE, Caudle KE, Gaedigk A; Clinical Pharmacogenetics Implementation Consortium. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6 and CYP2C19 Genotypes and Dosing of Selective Serotonin Reuptake Inhibitors. Clin Pharmacol Ther. 2015 Aug;98(2):127-34. doi: 10.1002/cpt.147. Epub 2015 Jun 29.
PubMed 25974703Crews KR, Gaedigk A, Dunnenberger HM, Klein TE, Shen DD, Callaghan JT, Kharasch ED, Skaar TC; Clinical Pharmacogenetics Implementation Consortium. Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines for codeine therapy in the context of cytochrome P450 2D6 (CYP2D6) genotype. Clin Pharmacol Ther. 2012 Feb;91(2):321-6. doi: 10.1038/clpt.2011.287. Epub 2011 Dec 28.
PubMed 22205192Sohn DR, Kusaka M, Ishizaki T, Shin SG, Jang IJ, Shin JG, Chiba K. Incidence of S-mephenytoin hydroxylation deficiency in a Korean population and the interphenotypic differences in diazepam pharmacokinetics. Clin Pharmacol Ther. 1992 Aug;52(2):160-9. doi: 10.1038/clpt.1992.125.
PubMed 1505151Bernard S, Neville KA, Nguyen AT, Flockhart DA. Interethnic differences in genetic polymorphisms of CYP2D6 in the U.S. population: clinical implications. Oncologist. 2006 Feb;11(2):126-35. doi: 10.1634/theoncologist.11-2-126.
PubMed 16476833Wijnen PA, Op den Buijsch RA, Drent M, Kuijpers PM, Neef C, Bast A, Bekers O, Koek GH. Review article: The prevalence and clinical relevance of cytochrome P450 polymorphisms. Aliment Pharmacol Ther. 2007 Dec;26 Suppl 2:211-9. doi: 10.1111/j.1365-2036.2007.03490.x.
PubMed 18081664Linares OA, Fudin J, Daly AL, Boston RC. Individualized Hydrocodone Therapy Based on Phenotype, Pharmacogenetics, and Pharmacokinetic Dosing. Clin J Pain. 2015 Dec;31(12):1026-35. doi: 10.1097/AJP.0000000000000214.
PubMed 25621429Falzone E, Hoffmann C, Keita H. Postoperative analgesia in elderly patients. Drugs Aging. 2013 Feb;30(2):81-90. doi: 10.1007/s40266-012-0047-7.
PubMed 23288604Balhara YP, Jain R. A urinalysis-based study of buprenorphine and non-prescription opioid use among patients on buprenorphine maintenance. J Pharmacol Pharmacother. 2012 Jan;3(1):15-9. doi: 10.4103/0976-500X.92496.
PubMed 22368411Christo PJ, Manchikanti L, Ruan X, Bottros M, Hansen H, Solanki DR, Jordan AE, Colson J. Urine drug testing in chronic pain. Pain Physician. 2011 Mar-Apr;14(2):123-43.
PubMed 21412368Uher R, Farmer A, Henigsberg N, Rietschel M, Mors O, Maier W, Kozel D, Hauser J, Souery D, Placentino A, Strohmaier J, Perroud N, Zobel A, Rajewska-Rager A, Dernovsek MZ, Larsen ER, Kalember P, Giovannini C, Barreto M, McGuffin P, Aitchison KJ. Adverse reactions to antidepressants. Br J Psychiatry. 2009 Sep;195(3):202-10. doi: 10.1192/bjp.bp.108.061960.
PubMed 19721108Vilhelmsson A, Svensson T, Meeuwisse A, Carlsten A. What can we learn from consumer reports on psychiatric adverse drug reactions with antidepressant medication? Experiences from reports to a consumer association. BMC Clin Pharmacol. 2011 Oct 25;11:16. doi: 10.1186/1472-6904-11-16.
PubMed 22026961Fabbri C, Serretti A. Pharmacogenetics of major depressive disorder: top genes and pathways toward clinical applications. Curr Psychiatry Rep. 2015 Jul;17(7):50. doi: 10.1007/s11920-015-0594-9.
PubMed 25980509Kreyenbuhl JA, Valenstein M, McCarthy JF, Ganoczy D, Blow FC. Long-term antipsychotic polypharmacy in the VA health system: patient characteristics and treatment patterns. Psychiatr Serv. 2007 Apr;58(4):489-95. doi: 10.1176/ps.2007.58.4.489.
PubMed 17412850
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens: SPHERE
- ClinicalTrials.gov ID
- NCT02625155
- Acronym / sponsor ID
- SPHERE / 2017-001
- Conditions
- Target Drug-related Adverse Events
- Keywords
- Pharmacogenomics, Urine Drug Testing, antidepressants, benzodiazepines, opioids, muscle relaxants, non-steroidal anti-inflammatory agents, TDRAE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14,000 participants (estimated)
- Lead sponsor
- InSource DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Study start
- Dec 2015
- Primary completion
- Dec 2018 (estimated)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC Arm) | Other | Other: Urine diagnostic testing as SOC, drug regimen changes per SOCStandard of Care UDT |
| Selective PGx Testing (Test Arm) | Other | Other: Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test resultsStandard of Care UDT with selective PGx testing |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) |
Primary outcome
The proportion of subjects who experience target drug-related adverse events (TDRAE) over the 90-day period following enrollment
Time frame: 90 days
7 secondary outcomes
All TDRAE as quantified within each of the four classes of medications
Time frame: 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
Severe TDRAE, defined as a TDRAE that meets the criteria for a Serious Adverse Event
Time frame: 90 days
Ineffective therapeutic response, determined by the Investigator
Time frame: 90 days
Supra-therapeutic response, as determined by the Investigator
Time frame: 90 days
Frequency of subjects with changes in drug regimen
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Background: PubMed 22356329Phimister EG, Feero WG, Guttmacher AE. Realizing genomic medicine. N Engl J Med. 2012 Feb 23;366(8):757-9. doi: 10.1056/NEJMe1200749. No abstract available.
- Background: PubMed 18591960Rebsamen MC, Desmeules J, Daali Y, Chiappe A, Diemand A, Rey C, Chabert J, Dayer P, Hochstrasser D, Rossier MF. The AmpliChip CYP450 test: cytochrome P450 2D6 genotype assessment and phenotype prediction. Pharmacogenomics J. 2009 Feb;9(1):34-41. doi: 10.1038/tpj.2008.7. Epub 2008 Jul 1.
- Background: PubMed 25974703Hicks JK, Bishop JR, Sangkuhl K, Muller DJ, Ji Y, Leckband SG, Leeder JS, Graham RL, Chiulli DL, LLerena A, Skaar TC, Scott SA, Stingl JC, Klein TE, Caudle KE, Gaedigk A; Clinical Pharmacogenetics Implementation Consortium. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6 and CYP2C19 Genotypes and Dosing of Selective Serotonin Reuptake Inhibitors. Clin Pharmacol Ther. 2015 Aug;98(2):127-34. doi: 10.1002/cpt.147. Epub 2015 Jun 29.
- Background: PubMed 22205192Crews KR, Gaedigk A, Dunnenberger HM, Klein TE, Shen DD, Callaghan JT, Kharasch ED, Skaar TC; Clinical Pharmacogenetics Implementation Consortium. Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines for codeine therapy in the context of cytochrome P450 2D6 (CYP2D6) genotype. Clin Pharmacol Ther. 2012 Feb;91(2):321-6. doi: 10.1038/clpt.2011.287. Epub 2011 Dec 28.
- Background: PubMed 1505151Sohn DR, Kusaka M, Ishizaki T, Shin SG, Jang IJ, Shin JG, Chiba K. Incidence of S-mephenytoin hydroxylation deficiency in a Korean population and the interphenotypic differences in diazepam pharmacokinetics. Clin Pharmacol Ther. 1992 Aug;52(2):160-9. doi: 10.1038/clpt.1992.125.
- Background: PubMed 16476833Bernard S, Neville KA, Nguyen AT, Flockhart DA. Interethnic differences in genetic polymorphisms of CYP2D6 in the U.S. population: clinical implications. Oncologist. 2006 Feb;11(2):126-35. doi: 10.1634/theoncologist.11-2-126.
- Background: PubMed 18081664Wijnen PA, Op den Buijsch RA, Drent M, Kuijpers PM, Neef C, Bast A, Bekers O, Koek GH. Review article: The prevalence and clinical relevance of cytochrome P450 polymorphisms. Aliment Pharmacol Ther. 2007 Dec;26 Suppl 2:211-9. doi: 10.1111/j.1365-2036.2007.03490.x.
- Background: PubMed 25621429Linares OA, Fudin J, Daly AL, Boston RC. Individualized Hydrocodone Therapy Based on Phenotype, Pharmacogenetics, and Pharmacokinetic Dosing. Clin J Pain. 2015 Dec;31(12):1026-35. doi: 10.1097/AJP.0000000000000214.
- Background: PubMed 23288604Falzone E, Hoffmann C, Keita H. Postoperative analgesia in elderly patients. Drugs Aging. 2013 Feb;30(2):81-90. doi: 10.1007/s40266-012-0047-7.
- Background: PubMed 22368411Balhara YP, Jain R. A urinalysis-based study of buprenorphine and non-prescription opioid use among patients on buprenorphine maintenance. J Pharmacol Pharmacother. 2012 Jan;3(1):15-9. doi: 10.4103/0976-500X.92496.
- Background: PubMed 21412368Christo PJ, Manchikanti L, Ruan X, Bottros M, Hansen H, Solanki DR, Jordan AE, Colson J. Urine drug testing in chronic pain. Pain Physician. 2011 Mar-Apr;14(2):123-43.
- Background: PubMed 19721108Uher R, Farmer A, Henigsberg N, Rietschel M, Mors O, Maier W, Kozel D, Hauser J, Souery D, Placentino A, Strohmaier J, Perroud N, Zobel A, Rajewska-Rager A, Dernovsek MZ, Larsen ER, Kalember P, Giovannini C, Barreto M, McGuffin P, Aitchison KJ. Adverse reactions to antidepressants. Br J Psychiatry. 2009 Sep;195(3):202-10. doi: 10.1192/bjp.bp.108.061960.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Urine diagnostic testing as SOC, drug regimen changes per SOC and Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results in people with Target Drug-related Adverse Events, run by InSource Diagnostics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02625155, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.