Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens (SPHERE)
27 de febrero de 2018 actualizado por: 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.
Descripción general del estudio
Estado
Desconocido
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
14000
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Tennessee
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Tazewell, Tennessee, Estados Unidos, 37879
- Reclutamiento
- Donald H. Deaton, Jr., DO
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Contacto:
- Donald H. Deaton, DO
- Número de teléfono: 423-259-8076
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Investigador principal:
- Donald H. Deaton, DO
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
12 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Standard of Care (SOC Arm)
Standard of Care UDT
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|
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Otro: Selective PGx Testing (Test Arm)
Standard of Care UDT with selective PGx testing
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The proportion of subjects who experience target drug-related adverse events (TDRAE) over the 90-day period following enrollment
Periodo de tiempo: 90 days
|
90 days
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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All TDRAE as quantified within each of the four classes of medications
Periodo de tiempo: 90 days
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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)
Periodo de tiempo: 90 days
|
90 days
|
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Severe TDRAE, defined as a TDRAE that meets the criteria for a Serious Adverse Event
Periodo de tiempo: 90 days
|
90 days
|
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Ineffective therapeutic response, determined by the Investigator
Periodo de tiempo: 90 days
|
90 days
|
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Supra-therapeutic response, as determined by the Investigator
Periodo de tiempo: 90 days
|
90 days
|
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Frequency of subjects with changes in drug regimen
Periodo de tiempo: 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
Periodo de tiempo: 90 days
|
90 days
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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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.
- Hamburg MA, Collins FS. The path to personalized medicine. N Engl J Med. 2010 Jul 22;363(4):301-4. doi: 10.1056/NEJMp1006304. Epub 2010 Jun 15. No abstract available. Erratum In: N Engl J Med. 2010 Sep 9;363(11):1092.
- 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.
- Sohn 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.
- 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.
- Kreyenbuhl 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.
- Gurwitz JH, Field TS, Avorn J, McCormick D, Jain S, Eckler M, Benser M, Edmondson AC, Bates DW. Incidence and preventability of adverse drug events in nursing homes. Am J Med. 2000 Aug 1;109(2):87-94. doi: 10.1016/s0002-9343(00)00451-4.
- Moeller KE, Lee KC, Kissack JC. Urine drug screening: practical guide for clinicians. Mayo Clin Proc. 2008 Jan;83(1):66-76. doi: 10.4065/83.1.66. Erratum In: Mayo Clin Proc. 2008 Jul;83(7):851.
- Crews KR, Hicks JK, Pui CH, Relling MV, Evans WE. Pharmacogenomics and individualized medicine: translating science into practice. Clin Pharmacol Ther. 2012 Oct;92(4):467-75. doi: 10.1038/clpt.2012.120. Epub 2012 Sep 5.
- Yiannakopoulou E. Pharmacogenomics and Opioid Analgesics: Clinical Implications. Int J Genomics. 2015;2015:368979. doi: 10.1155/2015/368979. Epub 2015 May 14.
- Stanek EJ, Sanders CL, Taber KA, Khalid M, Patel A, Verbrugge RR, Agatep BC, Aubert RE, Epstein RS, Frueh FW. Adoption of pharmacogenomic testing by US physicians: results of a nationwide survey. Clin Pharmacol Ther. 2012 Mar;91(3):450-8. doi: 10.1038/clpt.2011.306. Epub 2012 Jan 25.
- Deverka PA. Pharmacogenomics, evidence, and the role of payers. Public Health Genomics. 2009;12(3):149-57. doi: 10.1159/000189627. Epub 2009 Feb 10.
- 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.)
- Manchikanti L, Atluri S, Trescot AM, Giordano J. Monitoring opioid adherence in chronic pain patients: tools, techniques, and utility. Pain Physician. 2008 Mar;11(2 Suppl):S155-80.
- Konstantinova SV, Normann PT, Arnestad M, Karinen R, Christophersen AS, Morland J. Morphine to codeine concentration ratio in blood and urine as a marker of illicit heroin use in forensic autopsy samples. Forensic Sci Int. 2012 Apr 10;217(1-3):216-21. doi: 10.1016/j.forsciint.2011.11.007. Epub 2011 Dec 2.
- Standridge JB, Adams SM, Zotos AP. Urine drug screening: a valuable office procedure. Am Fam Physician. 2010 Mar 1;81(5):635-40.
- 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.
- 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.
- Wiedemer NL, Harden PS, Arndt IO, Gallagher RM. The opioid renewal clinic: a primary care, managed approach to opioid therapy in chronic pain patients at risk for substance abuse. Pain Med. 2007 Oct-Nov;8(7):573-84. doi: 10.1111/j.1526-4637.2006.00254.x.
- Manchikanti L, Manchikanti KN, Pampati V, Cash KA. Prevalence of side effects of prolonged low or moderate dose opioid therapy with concomitant benzodiazepine and/or antidepressant therapy in chronic non-cancer pain. Pain Physician. 2009 Jan-Feb;12(1):259-67.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de diciembre de 2015
Finalización primaria (Anticipado)
1 de diciembre de 2018
Fechas de registro del estudio
Enviado por primera vez
25 de noviembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
8 de diciembre de 2015
Publicado por primera vez (Estimar)
9 de diciembre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de febrero de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
27 de febrero de 2018
Última verificación
1 de marzo de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2017-001
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .