Recruiting

Pharmacogenomic Testing

Sponsor:

General Genetics Corporation

Code:

NCT02095769

Conditions

Genetics of Drug Metabolism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The goal of the POETRY Registry is to determine whether data from Pharmacogenomic (PGx) Testing for elderly and disabled patients can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug events, hospitalizations, and emergency department visits.

The way an individual processes or metabolizes a drug is in part determined by their genes, and there is known to be genetic variation from one human to another. The study of the way in which genes affect an individual's response to drugs is known as "Pharmacogenomics."

Conditions

Genetics of Drug Metabolism

Study ID

NCT02095769

Start date

Apr, 2014

Status verified date

Feb, 2015

Completion date

Jan, 2017

Anticipated

Primary completion date

Jan, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subject underwent PGx testing for the alleles appropriate to the target drugs within the prior 90 days ('index PGx test')
  • Males and females aged ≥65 years or male and females aged ≥18 years who have a disability
  • Subject is able and willing to provide written informed consent
  • Subject was receiving at least one medication known to be associated with allelic variation at the time of the index PGx test, including over-the-counter medications
  • Subject has a history of at least one target drug-related adverse event (TDAE) over the 12-month period preceding receipt of PGx test results, or has experienced inadequate efficacy from a target drug

Exclusion Criteria:

  • Subject is currently hospitalized
  • Subject's medical and medication history is unavailable over the 90-day period preceding the receipt of PGx test results
  • Subject is unable to provide an accurate history due to mental incapacity
  • Subject is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Registry

Study Design

Enrollment

280000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Occurrence of Meaningful Change in Drug Regimen [ Time Frame: 90 days ]

Central Contacts and Locations

Locations

Core Insitute

Recruiting

Phoenix, Arizona, United States, 85023

Contacts

Eric Feldman, MD

623-537-5695eric.feldman@thecoreinstitute.com

Principal Investigator:

Eric Feldman, MD

LifeSpan Institute

Recruiting

La Jolla, California, United States, 92037

Contacts

Steven A Brody, M.D., Ph.D.

858-344-5020sbrodymd@lifespan-md.com

Principal Investigator:

Steven A Brody, M.D., Ph.D.

The International Heart & Lung Institute Center for Restorative Medicine

Recruiting

Palm Springs, California, United States, 92262

Contacts

Steven Gundry, MD

760-323-5553DocSRG@aol.com

Principal Investigator:

Steven Gundry, MD

Research Physicians Network Alliance

Recruiting

Pembroke Pines, Florida, United States, 33026

Contacts

Perry Krichmar, MD

954-237-6286pkrichmar@rpna.net

Principal Investigator:

Perry Krichmar, MD

Tallahassee Neurological Institute

Recruiting

Tallahassee, Florida, United States, 32308

Contacts

Lutheria Hollis

850-877-5115lhollis@tnc-neuro.com

Principal Investigator:

Matthew Lawson, MD

Hypertension Institute

Recruiting

Nashville, Tennessee, United States, 37205

Contacts

Mark Houston, MD

615-512-1481boohouston@comcast.net

Principal Investigator:

Mark C Houston, M.D.

Diagnostic Clinic of Houston

Recruiting

Houston, Texas, United States, 77004

Contacts

Freemu Varghese, MD

fvarghese@diagnosticclinic.com

Principal Investigator:

Freemu Varghese, MD

More Information

Sponsor

General Genetics Corporation

Last update posted

Feb 24, 2015

Last verified

Feb, 2015

Keywords

  • Pharmacogenomics
  • Adverse Drug Reactions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by General Genetics Corporation on 2015-02-24.