Diagnosing Adverse Drug Reactions Registry

Status unconfirmed

Conditions studied: Genetics of Drug Metabolism

In brief

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.

Key facts

Study ID

NCT01970709

Run by

Renaissance RX

People needed

250000

Starts

2013-11-01

Last updated by the study team

2015-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Edwards Lake Medical Center — Birmingham, Alabama, United States
• Gerald Harris MD — Glendale, Arizona, United States
• Holland Center for Family Health — Peoria, Arizona, United States
• AZ Pain Center — Phoenix, Arizona, United States
• Olga Voroshilovsky — Los Angeles, California, United States
• Institute for Regenerative Medicine and Clinical Research — Pasadena, California, United States
• Boulder Medical Center — Boulder, Colorado, United States
• Prime Healthcare - Anthony Roselli MD — Avon, Connecticut, United States
• Washington Pain Center — Washington D.C., District of Columbia, United States
• Continental Research Network — Doral, Florida, United States
• Latin Foundation for Health — Miami, Florida, United States
• Primary Care Associates, P.A. — Stuart, Florida, United States
• Roman Medical Group — Columbus, Georgia, United States
• Wellness Medicine — Hampton, Georgia, United States
• Ocmulgee Physicians — Macon, Georgia, United States
• Macon Family Health Center Inc. — Macon, Georgia, United States
• Your Personal Physician — Rome, Georgia, United States
• Valley Health Care — Rome, Georgia, United States
• Dr. B. Abraham PC — Snellville, Georgia, United States
• Candler Internal Medicine — Statesboro, Georgia, United States
• Primary Health Associates — Orland Park, Illinois, United States
• Women's Care Center — Lexington, Kentucky, United States
• Healthy Heart Cardiology — Grandville, Michigan, United States
• Heart Cardiology Consultants — Southfield, Michigan, United States
• Union Square Medical Associates, PC — Elizabeth, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.