Diagnosing Adverse Drug Reactions Registry

NCT01970709 | Unknown

• 1 other identifier: 2013-101
• Study Type: observational
• Target: 250,000
• Locations: 1 country
• Sites: 49

Brief Summary

This multicenter Registry is to assess whether the use of pharmacogenomic data results in a meaningful change in a subject's drug or dose regimen. In addition, the Registry will evaluate the relationship between adverse drug reactions (ADR) and genotype and assess resource utilization (emergency department visits and hospitalizations) associated with ADR.

Conditions

Genetics of Drug Metabolism

Keywords

Adverse Drug Reactions; Emergency Department Visits; Hospitalizations; Pharmacogenomic

Outcome Measures

Primary Outcomes (1)

• Occurrence of meaningful change in drug regimen

  The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each subject when: * A genotype known to affect a drug the subject is taking is identified, and * The subject's treating physician makes at least one drug regimen change in concordance with the PharmD recommendations.

  60 days

Secondary Outcomes (4)

• Change in the regimen of drugs controlled by genes of interest over the 12 months prior to enrollment and change in the regimen of drugs controlled by genes of interest over the 60 days following receipt of pharmacogenetic test results.

  60 days

• Number of ADR per month over the 12 months prior to enrollment and number of ADR per month over the 60 days following receipt of pharmacogenomic test results.

  60 days

• Frequency of genome-based PharmD recommendations to alter drug or dose.

  60 days

• Emergency department visits and hospitalizations

  60 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects over the age of 18, taking three or more medications, two of which are metabolized by the CYP450 pathway.

You may qualify if:

• Subject has care coordinated at the treating physician's outpatient clinic;
• Subject has provided written informed consent;
• Subject is taking at least three (3) regularly scheduled medications, excluding as needed (PRN) medications, over the counter medications and nutritional supplements; two (2) of which are known to be affected by genetic allelic variation.
• Subject's treating physician has a clinical suspicion that the subject is experiencing adverse signs or symptoms related to a prescribed medication or is not achieving the intended effect from the medication.

You may not qualify if:

• Subject has a history of chronic renal dysfunction, Chronic Kidney Disease Stage 4 or 5;
• Subject has a history of abnormal hepatic function within the last 2 years (INR \>1.2 not attributable to anticoagulant medications, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) \>1.5x normal, or suspected cirrhosis);
• Subject has a history of malabsorption (short gut syndrome);
• Subject has a history of any gastric or small bowel surgery;
• Subject is currently hospitalized;
• Subject is currently being treated with intravenous medication;
• Subject underwent prior pharmacogenomic testing with results reported within the last 12 months.
• Subjects may be eligible within 60 days from the date of pharmacogenomic testing.

Sponsors & Collaborators

• Renaissance RX: lead
• Syntactx: collaborator

Study Sites (49)

Edwards Lake Medical Center

Birmingham, Alabama, 35235, United States

Location

Gerald Harris MD

Glendale, Arizona, 85308, United States

Location

Holland Center for Family Health

Peoria, Arizona, 85381, United States

Location

AZ Pain Center

Phoenix, Arizona, 85032, United States

Location

Olga Voroshilovsky

Los Angeles, California, 90048, United States

Location

Institute for Regenerative Medicine and Clinical Research

Pasadena, California, 91105, United States

Location

Boulder Medical Center

Boulder, Colorado, 80304, United States

Location

Prime Healthcare - Anthony Roselli MD

Avon, Connecticut, 06001, United States

Location

Washington Pain Center

Washington D.C., District of Columbia, 20016, United States

Location

Continental Research Network

Doral, Florida, 33126, United States

Location

Latin Foundation for Health

Miami, Florida, 33144, United States

Location

Primary Care Associates, P.A.

Stuart, Florida, 34994, United States

Location

Roman Medical Group

Columbus, Georgia, 31904, United States

Location

Wellness Medicine

Hampton, Georgia, 30228, United States

Location

Ocmulgee Physicians

Macon, Georgia, 31201, United States

Location

Macon Family Health Center Inc.

Macon, Georgia, 31204, United States

Location

Your Personal Physician

Rome, Georgia, 30161, United States

Location

Valley Health Care

Rome, Georgia, 30165, United States

Location

Dr. B. Abraham PC

Snellville, Georgia, 30039, United States

Location

Candler Internal Medicine

Statesboro, Georgia, 30458, United States

Location

Primary Health Associates

Orland Park, Illinois, 60467, United States

Location

Women's Care Center

Lexington, Kentucky, 40503, United States

Location

Healthy Heart Cardiology

Grandville, Michigan, 49418, United States

Location

Heart Cardiology Consultants

Southfield, Michigan, 48075, United States

Location

Union Square Medical Associates, PC

Elizabeth, New Jersey, 07208, United States

Location

United Medical PC

Lyndhurst, New Jersey, 07071, United States

Location

Internal Medicine Specialists of Alamogordo, P.C.

Alamogordo, New Mexico, 88310, United States

Location

Lovelace Rehabilitation Hospital

Albuquerque, New Mexico, 87102, United States

Location

Sage Neuroscience Center

Albuquerque, New Mexico, 87109, United States

Location

Geriatrics Associates, PAC

Albuquerque, New Mexico, 87113, United States

Location

Isabel C Vigil MD

Las Cruces, New Mexico, 88005, United States

Location

Larry F Berman MD PC

Charlotte, North Carolina, 28210-0106, United States

Location

Lakewood Pediatrics and Family Medicine

Durham, North Carolina, 27704, United States

Location

Carolina Urology Partners

Gastonia, North Carolina, 28054, United States

Location

Carolina Neurosurgery and Spine Associates

Greensboro, North Carolina, 27401, United States

Location

Comprehensive Pain Center

Columbus, Ohio, 43213, United States

Location

Knightsbridge Internal Medicine and Cardiology Associates, Inc

Columbus, Ohio, 43214, United States

Location

Gateway Health and Wellness LLC

Columbus, Ohio, 43215, United States

Location

Robert E Barkett Jr MD

Mansfield, Ohio, 44907, United States

Location

Midwestern Internal Medicine Associates (MIMA)

Marion, Ohio, 43302, United States

Location

Stonegate Family Health

Reynoldsburg, Ohio, 43068, United States

Location

Primary Care Associates - Unity

Tallmadge, Ohio, 44278, United States

Location

Easton Cardiovascular Associates

Easton, Pennsylvania, 18042, United States

Location

Carolina Center For Advanced Management Of Pain

Greenville, South Carolina, 29601, United States

Location

Colonial Family Practice

Sumter, South Carolina, 29150, United States

Location

Palmetto Adult Medicine

Sumter, South Carolina, 29150, United States

Location

Parkway Cardiology Associates

Oak Ridge, Tennessee, 37830, United States

Location

Mark A. Sanders, DO

Fort Worth, Texas, 76107, United States

Location

Emporia Medical Associates

Emporia, Virginia, 23847, United States

Location

Related Publications (15)

• Onder G, Petrovic M, Tangiisuran B, Meinardi MC, Markito-Notenboom WP, Somers A, Rajkumar C, Bernabei R, van der Cammen TJ. Development and validation of a score to assess risk of adverse drug reactions among in-hospital patients 65 years or older: the GerontoNet ADR risk score. Arch Intern Med. 2010 Jul 12;170(13):1142-8. doi: 10.1001/archinternmed.2010.153.

  PMID: 20625022 BACKGROUND

• Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998 Apr 15;279(15):1200-5. doi: 10.1001/jama.279.15.1200.

  PMID: 9555760 BACKGROUND

• Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011 Nov 24;365(21):2002-12. doi: 10.1056/NEJMsa1103053.

  PMID: 22111719 BACKGROUND

• Mallet L, Spinewine A, Huang A. The challenge of managing drug interactions in elderly people. Lancet. 2007 Jul 14;370(9582):185-191. doi: 10.1016/S0140-6736(07)61092-7.

  PMID: 17630042 BACKGROUND

• Epstein RS, Moyer TP, Aubert RE, O Kane DJ, Xia F, Verbrugge RR, Gage BF, Teagarden JR. Warfarin genotyping reduces hospitalization rates results from the MM-WES (Medco-Mayo Warfarin Effectiveness study). J Am Coll Cardiol. 2010 Jun 22;55(25):2804-12. doi: 10.1016/j.jacc.2010.03.009. Epub 2010 Apr 8.

  PMID: 20381283 BACKGROUND

• Wang L, McLeod HL, Weinshilboum RM. Genomics and drug response. N Engl J Med. 2011 Mar 24;364(12):1144-53. doi: 10.1056/NEJMra1010600. No abstract available.

  PMID: 21428770 BACKGROUND

• Aronson JK. Adverse drug reactions--no farewell to harms. Br J Clin Pharmacol. 2007 Feb;63(2):131-5. doi: 10.1111/j.1365-2125.2006.02860.x. No abstract available.

  PMID: 17274787 BACKGROUND

• Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000 Oct 7;356(9237):1255-9. doi: 10.1016/S0140-6736(00)02799-9.

  PMID: 11072960 BACKGROUND

• Gage BF, Eby C, Johnson JA, Deych E, Rieder MJ, Ridker PM, Milligan PE, Grice G, Lenzini P, Rettie AE, Aquilante CL, Grosso L, Marsh S, Langaee T, Farnett LE, Voora D, Veenstra DL, Glynn RJ, Barrett A, McLeod HL. Use of pharmacogenetic and clinical factors to predict the therapeutic dose of warfarin. Clin Pharmacol Ther. 2008 Sep;84(3):326-31. doi: 10.1038/clpt.2008.10. Epub 2008 Feb 27.

  PMID: 18305455 BACKGROUND

• International Warfarin Pharmacogenetics Consortium; Klein TE, Altman RB, Eriksson N, Gage BF, Kimmel SE, Lee MT, Limdi NA, Page D, Roden DM, Wagner MJ, Caldwell MD, Johnson JA. Estimation of the warfarin dose with clinical and pharmacogenetic data. N Engl J Med. 2009 Feb 19;360(8):753-64. doi: 10.1056/NEJMoa0809329.

  PMID: 19228618 BACKGROUND

• Garcia DA, Lopes RD, Hylek EM. New-onset atrial fibrillation and warfarin initiation: high risk periods and implications for new antithrombotic drugs. Thromb Haemost. 2010 Dec;104(6):1099-105. doi: 10.1160/TH10-07-0491. Epub 2010 Sep 30.

  PMID: 20886196 BACKGROUND

• Meckley LM, Gudgeon JM, Anderson JL, Williams MS, Veenstra DL. A policy model to evaluate the benefits, risks and costs of warfarin pharmacogenomic testing. Pharmacoeconomics. 2010;28(1):61-74. doi: 10.2165/11318240-000000000-00000.

  PMID: 20014877 BACKGROUND

• Relling MV, Klein TE. CPIC: Clinical Pharmacogenetics Implementation Consortium of the Pharmacogenomics Research Network. Clin Pharmacol Ther. 2011 Mar;89(3):464-7. doi: 10.1038/clpt.2010.279. Epub 2011 Jan 26.

  PMID: 21270786 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.

  PMID: 12700376 BACKGROUND

• Huhtakangas J, Tetri S, Juvela S, Saloheimo P, Bode MK, Hillbom M. Effect of increased warfarin use on warfarin-related cerebral hemorrhage: a longitudinal population-based study. Stroke. 2011 Sep;42(9):2431-5. doi: 10.1161/STROKEAHA.111.615260. Epub 2011 Jul 28.

  PMID: 21799168 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Buccal swab

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Target Duration: 60 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: October 28, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2015
• Last Updated: March 19, 2015

Record last verified: 2015-03

Locations

US (49)