Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens (SPHERE)
27. februar 2018 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Studietype
Intervensjonell
Registrering (Forventet)
14000
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Tennessee
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Tazewell, Tennessee, Forente stater, 37879
- Rekruttering
- Donald H. Deaton, Jr., DO
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Ta kontakt med:
- Donald H. Deaton, DO
- Telefonnummer: 423-259-8076
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Hovedetterforsker:
- Donald H. Deaton, DO
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
12 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: Standard of Care (SOC Arm)
Standard of Care UDT
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|
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Annen: Selective PGx Testing (Test Arm)
Standard of Care UDT with selective PGx testing
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The proportion of subjects who experience target drug-related adverse events (TDRAE) over the 90-day period following enrollment
Tidsramme: 90 days
|
90 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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All TDRAE as quantified within each of the four classes of medications
Tidsramme: 90 days
|
90 days
|
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TDRAE driving a change in the subject's drug regimen (dose change, discontinuation, substation, or addition of a new drug)
Tidsramme: 90 days
|
90 days
|
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Severe TDRAE, defined as a TDRAE that meets the criteria for a Serious Adverse Event
Tidsramme: 90 days
|
90 days
|
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Ineffective therapeutic response, determined by the Investigator
Tidsramme: 90 days
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90 days
|
|
Supra-therapeutic response, as determined by the Investigator
Tidsramme: 90 days
|
90 days
|
|
Frequency of subjects with changes in drug regimen
Tidsramme: 90 days
|
90 days
|
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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
Tidsramme: 90 days
|
90 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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- Crews 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.
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2015
Primær fullføring (Forventet)
1. desember 2018
Datoer for studieregistrering
Først innsendt
25. november 2015
Først innsendt som oppfylte QC-kriteriene
8. desember 2015
Først lagt ut (Anslag)
9. desember 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. februar 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. februar 2018
Sist bekreftet
1. mars 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2017-001
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .