Diagnosing Adverse Drug Reactions Registry
- Conditions
- Genetics of Drug Metabolism
- Registration Number
- NCT01970709
- Lead Sponsor
- Renaissance RX
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250000
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of meaningful change in drug regimen 60 days 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.
- Secondary Outcome Measures
Name Time Method 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 Emergency department visits and hospitalizations 60 days Emergency department visits over the 12 months prior to enrollment, emergency department visits over the 60 days following receipt of test results, hospitalizations over the 12 months prior to enrollment, and hospitalizations over the 60 days following receipt of test results.
Frequency of genome-based PharmD recommendations to alter drug or dose. 60 days
Trial Locations
- Locations (49)
Latin Foundation for Health
🇺🇸Miami, Florida, United States
Heart Cardiology Consultants
🇺🇸Southfield, Michigan, United States
Gateway Health and Wellness LLC
🇺🇸Columbus, Ohio, United States
Institute for Regenerative Medicine and Clinical Research
🇺🇸Pasadena, California, United States
Roman Medical Group
🇺🇸Columbus, Georgia, United States
Boulder Medical Center
🇺🇸Boulder, Colorado, United States
Lovelace Rehabilitation Hospital
🇺🇸Albuquerque, New Mexico, United States
Sage Neuroscience Center
🇺🇸Albuquerque, New Mexico, United States
Macon Family Health Center Inc.
🇺🇸Macon, Georgia, United States
Prime Healthcare - Anthony Roselli MD
🇺🇸Avon, Connecticut, United States
Gerald Harris MD
🇺🇸Glendale, Arizona, United States
Olga Voroshilovsky
🇺🇸Los Angeles, California, United States
Ocmulgee Physicians
🇺🇸Macon, Georgia, United States
AZ Pain Center
🇺🇸Phoenix, Arizona, United States
Dr. B. Abraham PC
🇺🇸Snellville, Georgia, United States
Primary Health Associates
🇺🇸Orland Park, Illinois, United States
Washington Pain Center
🇺🇸Washington, District of Columbia, United States
Wellness Medicine
🇺🇸Hampton, Georgia, United States
Stonegate Family Health
🇺🇸Reynoldsburg, Ohio, United States
Continental Research Network
🇺🇸Doral, Florida, United States
Holland Center for Family Health
🇺🇸Peoria, Arizona, United States
Primary Care Associates, P.A.
🇺🇸Stuart, Florida, United States
Your Personal Physician
🇺🇸Rome, Georgia, United States
Healthy Heart Cardiology
🇺🇸Grandville, Michigan, United States
Valley Health Care
🇺🇸Rome, Georgia, United States
Edwards Lake Medical Center
🇺🇸Birmingham, Alabama, United States
Robert E Barkett Jr MD
🇺🇸Mansfield, Ohio, United States
Easton Cardiovascular Associates
🇺🇸Easton, Pennsylvania, United States
Comprehensive Pain Center
🇺🇸Columbus, Ohio, United States
Knightsbridge Internal Medicine and Cardiology Associates, Inc
🇺🇸Columbus, Ohio, United States
Lakewood Pediatrics and Family Medicine
🇺🇸Durham, North Carolina, United States
Carolina Urology Partners
🇺🇸Gastonia, North Carolina, United States
Isabel C Vigil MD
🇺🇸Las Cruces, New Mexico, United States
Candler Internal Medicine
🇺🇸Statesboro, Georgia, United States
Internal Medicine Specialists of Alamogordo, P.C.
🇺🇸Alamogordo, New Mexico, United States
Union Square Medical Associates, PC
🇺🇸Elizabeth, New Jersey, United States
Women's Care Center
🇺🇸Lexington, Kentucky, United States
Geriatrics Associates, PAC
🇺🇸Albuquerque, New Mexico, United States
Larry F Berman MD PC
🇺🇸Charlotte, North Carolina, United States
United Medical PC
🇺🇸Lyndhurst, New Jersey, United States
Primary Care Associates - Unity
🇺🇸Tallmadge, Ohio, United States
Emporia Medical Associates
🇺🇸Emporia, Virginia, United States
Carolina Neurosurgery and Spine Associates
🇺🇸Greensboro, North Carolina, United States
Mark A. Sanders, DO
🇺🇸Fort Worth, Texas, United States
Carolina Center For Advanced Management Of Pain
🇺🇸Greenville, South Carolina, United States
Palmetto Adult Medicine
🇺🇸Sumter, South Carolina, United States
Parkway Cardiology Associates
🇺🇸Oak Ridge, Tennessee, United States
Colonial Family Practice
🇺🇸Sumter, South Carolina, United States
Midwestern Internal Medicine Associates (MIMA)
🇺🇸Marion, Ohio, United States