Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens (SPHERE)
27. Februar 2018 aktualisiert von: 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.
Studienübersicht
Status
Unbekannt
Bedingungen
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
14000
Phase
- Phase 4
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Tennessee
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Tazewell, Tennessee, Vereinigte Staaten, 37879
- Rekrutierung
- Donald H. Deaton, Jr., DO
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Kontakt:
- Donald H. Deaton, DO
- Telefonnummer: 423-259-8076
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Hauptermittler:
- Donald H. Deaton, DO
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
12 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: Standard of Care (SOC Arm)
Standard of Care UDT
|
|
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Sonstiges: Selective PGx Testing (Test Arm)
Standard of Care UDT with selective PGx testing
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
The proportion of subjects who experience target drug-related adverse events (TDRAE) over the 90-day period following enrollment
Zeitfenster: 90 days
|
90 days
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
All TDRAE as quantified within each of the four classes of medications
Zeitfenster: 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)
Zeitfenster: 90 days
|
90 days
|
|
Severe TDRAE, defined as a TDRAE that meets the criteria for a Serious Adverse Event
Zeitfenster: 90 days
|
90 days
|
|
Ineffective therapeutic response, determined by the Investigator
Zeitfenster: 90 days
|
90 days
|
|
Supra-therapeutic response, as determined by the Investigator
Zeitfenster: 90 days
|
90 days
|
|
Frequency of subjects with changes in drug regimen
Zeitfenster: 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
Zeitfenster: 90 days
|
90 days
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
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- Gandhi TK, Weingart SN, Borus J, Seger AC, Peterson J, Burdick E, Seger DL, Shu K, Federico F, Leape LL, Bates DW. Adverse drug events in ambulatory care. N Engl J Med. 2003 Apr 17;348(16):1556-64. doi: 10.1056/NEJMsa020703.
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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.
- 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.
- Rebsamen 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.
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- Bernard 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.
- Wijnen 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. Erratum In: Aliment Pharmacol Ther. 2009 Feb 1;29(3):350. Kuipers, P M J C [corrected to Kuijpers, P M J C].
- Linares 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.
- Falzone 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.
- Balhara 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.
- Christo 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.
- Uher 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. Erratum In: Br J Psychiatry. 2010 May;196(5):417.
- Vilhelmsson 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.
- Fabbri 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.
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- Michna E, Jamison RN, Pham LD, Ross EL, Janfaza D, Nedeljkovic SS, Narang S, Palombi D, Wasan AD. Urine toxicology screening among chronic pain patients on opioid therapy: frequency and predictability of abnormal findings. Clin J Pain. 2007 Feb;23(2):173-9. doi: 10.1097/AJP.0b013e31802b4f95.
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Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Dezember 2015
Primärer Abschluss (Voraussichtlich)
1. Dezember 2018
Studienanmeldedaten
Zuerst eingereicht
25. November 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. Dezember 2015
Zuerst gepostet (Schätzen)
9. Dezember 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
28. Februar 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
27. Februar 2018
Zuletzt verifiziert
1. März 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2017-001
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