Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens (SPHERE)
2018年2月27日 更新者：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.
調査の概要
状態
わからない
研究の種類
介入
入学 (予想される)
14000
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Tennessee
-
Tazewell、Tennessee、アメリカ、37879
- 募集
- Donald H. Deaton, Jr., DO
-
コンタクト：
- Donald H. Deaton, DO
- 電話番号：423-259-8076
-
主任研究者：
- Donald H. Deaton, DO
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
12年歳以上 (子、大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Standard of Care (SOC Arm)
Standard of Care UDT
|
|
|
他の：Selective PGx Testing (Test Arm)
Standard of Care UDT with selective PGx testing
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
The proportion of subjects who experience target drug-related adverse events (TDRAE) over the 90-day period following enrollment
時間枠：90 days
|
90 days
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
All TDRAE as quantified within each of the four classes of medications
時間枠：90 days
|
90 days
|
|
TDRAE driving a change in the subject's drug regimen (dose change, discontinuation, substation, or addition of a new drug)
時間枠：90 days
|
90 days
|
|
Severe TDRAE, defined as a TDRAE that meets the criteria for a Serious Adverse Event
時間枠：90 days
|
90 days
|
|
Ineffective therapeutic response, determined by the Investigator
時間枠：90 days
|
90 days
|
|
Supra-therapeutic response, as determined by the Investigator
時間枠：90 days
|
90 days
|
|
Frequency of subjects with changes in drug regimen
時間枠：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
時間枠：90 days
|
90 days
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年12月1日
一次修了 (予想される)
2018年12月1日
試験登録日
最初に提出
2015年11月25日
QC基準を満たした最初の提出物
2015年12月8日
最初の投稿 (見積もり)
2015年12月9日
学習記録の更新
投稿された最後の更新 (実際)
2018年2月28日
QC基準を満たした最後の更新が送信されました
2018年2月27日
最終確認日
2017年3月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2017-001
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。