Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens
NCT ID: NCT02625155
Last Updated: 2018-02-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
PHASE4
Total Enrollment
14000 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly (URGE)
NCT01786967
Urge Urinary Incontinence
COMPLETED
PHASE3
Two Phase Extension Trial of SP668 to Investigate the Safety and Tolerability of Sustained Release Fesoterodine in Subjects With Overactive Bladder: a Double-Blind Phase Followed by an Open-Label Extension Phase
NCT00220389
Overactive Bladder
COMPLETED
PHASE2
A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.
NCT00645281
Urinary Bladder, Overactive
COMPLETED
PHASE4
This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
NCT01286454
Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency
COMPLETED
PHASE1
Comparative Urine Proteomic Studies of Overactive Bladder in Humans
NCT01367886
Overactive Bladder
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Target Drug-related Adverse Events
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard of Care (SOC Arm)
Standard of Care UDT
Group Type
OTHER
Urine diagnostic testing as SOC, drug regimen changes per SOC
Intervention Type
OTHER
Selective PGx Testing (Test Arm)
Standard of Care UDT with selective PGx testing
Group Type
OTHER
Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results
Intervention Type
OTHER
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Urine diagnostic testing as SOC, drug regimen changes per SOC
Intervention Type
OTHER
Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Subject is 12 years of age or older;
2. Subject or legal representative is able and willing to provide informed consent;
3. 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;
4. Subject is scheduled for or is planned to be scheduled for UDT, ordered as per the treating healthcare provider's local standard of care;
5. 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.
2. Subject or legal representative is able and willing to provide informed consent;
3. 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;
4. Subject is scheduled for or is planned to be scheduled for UDT, ordered as per the treating healthcare provider's local standard of care;
5. 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
1. Prior history of PGx testing for genes specific to any of the target drugs in the past;
2. PGx testing is deemed mandatory in the opinion of the treating healthcare provider;
3. History of liver or renal transplantation;
4. Receiving chronic hemodialysis or peritoneal dialysis;
5. Currently hospitalized or in a long-term care facility;
6. Participation in another clinical trial that would, in the Investigator's opinion, interfere with the conduct of this study;
7. Subject or subject's guardian or advocate is unable to provide an accurate history of the subject's medical history, medications, and symptoms.
2. PGx testing is deemed mandatory in the opinion of the treating healthcare provider;
3. History of liver or renal transplantation;
4. Receiving chronic hemodialysis or peritoneal dialysis;
5. Currently hospitalized or in a long-term care facility;
6. Participation in another clinical trial that would, in the Investigator's opinion, interfere with the conduct of this study;
7. Subject or subject's guardian or advocate is unable to provide an accurate history of the subject's medical history, medications, and symptoms.
Minimum Eligible Age
12 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Syntactx
NETWORK
Sponsor Role
collaborator
InSource Diagnostics
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Donald H. Deaton, Jr., DO
Tazewell, Tennessee, United States
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
United States
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Donald H. Deaton, DO
Role: primary
423-259-8076
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Hicks 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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Yiannakopoulou E. Pharmacogenomics and Opioid Analgesics: Clinical Implications. Int J Genomics. 2015;2015:368979. doi: 10.1155/2015/368979. Epub 2015 May 14.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.)
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Standridge JB, Adams SM, Zotos AP. Urine drug screening: a valuable office procedure. Am Fam Physician. 2010 Mar 1;81(5):635-40.
Reference Type
BACKGROUND
Disability Evaluation Under Social Security. (Accessed 3/5/2014, 2014, at http://www.ssa.gov/disability/professionals/bluebook/general-info.htm.)
Reference Type
BACKGROUND
Inter-agency guideline for opioid dosing for chronic non-cancer pain.2010.
Reference Type
BACKGROUND
National Bioeconomy Blueprint. The White House; 2012:48.
Reference Type
BACKGROUND
World Guide for Drug Use and Pharmacogenomics. Corunna, Spain: EuroEspes Publishing; 2012.
Reference Type
BACKGROUND
Model policy on the use of opioid analgesics in the treatment of chronic pain. Federation of State Medical Boards; 2013.
Reference Type
BACKGROUND
ACOEM. Guidelines for the Chronic Use of Opioids. 2 ed: American College of Occupational and Environmental Medicine.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Special Investigation For Long Term Use Of Tolterodine (Regulatory Post Marketing Commitment Plan).
NCT00795509
COMPLETED
Pharmacokinetics and Relative Bioavailability Study
NCT01521767
COMPLETED
PHASE1
Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)
NCT00444925
COMPLETED
PHASE3
Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.
NCT00561951
COMPLETED
PHASE2
A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder
NCT00928070
COMPLETED
PHASE4
Exploring Predictors of Symptoms Relapse After Discontinuation of Treatment in Overactive Bladder (OAB) Patients
NCT00730535
COMPLETED
PHASE4
Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients
NCT01042236
COMPLETED
PHASE2
Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome
NCT00138723
COMPLETED
PHASE3
Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania
NCT03602508
COMPLETED
A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)
NCT00768521
COMPLETED
PHASE1
URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence
NCT04211831
COMPLETED
PHASE2
A Multicenter Trial to Investigate Fesoterodine Sustained Release in Overactive Bladder Syndrome
NCT00220363
COMPLETED
PHASE3
Bringing Simple Urge Incontinence Diagnosis & Treatment to Providers (BRIDGES)
NCT00862745
COMPLETED
PHASE4
Developing a Simple Test to Diagnose Overactive Bladder
NCT05572918
UNKNOWN
A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.
NCT01302054
COMPLETED
PHASE4
A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency
NCT00911937
COMPLETED
PHASE4
Fesoterodine Flexible Dose Study
NCT00536484
COMPLETED
PHASE3
Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.
NCT03175029
COMPLETED
PHASE2
Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder
NCT00746681
COMPLETED
PHASE2
Assessing the Genitourinary Microbiome of Women With Overactive Bladder Undergoing Onabotulinum Toxin Type A Intradetrusor Injections
NCT07025044
RECRUITING
Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive Bladder
NCT00479505
COMPLETED
PHASE2
Evaluate Efficacy and Safety Of Tolterodine Extended Release Capsule Compared With Tolterodine Immediate Release Tablet
NCT00139724
COMPLETED
PHASE3
Interventional Clinical Trial in Patients in Overactive Bladder With Nocturia in Women
NCT01729819
COMPLETED
PHASE2