Pharmacogenomic Testing Of the Elderly To Reduce Morbidity

Genetics of Drug Metabolism Clinical Trial

— POETRY  

Official title:

Pharmacogenomic Testing Of the Elderly To Reduce Morbidity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02095769
• Other study ID #: 201301
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2014
• Last updated: February 20, 2015
• Start date: April 2014
• Est. completion date: January 2017

Study information

• Verified date: February 2015
• Source: General Genetics Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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."

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280000
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Genetics of Drug Metabolism

Locations

Country	Name	City	State
Puerto Rico	Research & Cardiovascular Corp.	Ponce
United States	Diagnostic Clinic of Houston	Houston	Texas
United States	LifeSpan Institute	La Jolla	California
United States	Hypertension Institute	Nashville	Tennessee
United States	The International Heart & Lung Institute Center for Restorative Medicine	Palm Springs	California
United States	Research Physicians Network Alliance	Pembroke Pines	Florida
United States	Core Insitute	Phoenix	Arizona
United States	Tallahassee Neurological Institute	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
General Genetics Corporation	Syntactx

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 target drug regimen change, dose, substitution, or discontinuation.	90 days	No
Secondary	Binary occurrence of meaningful change in drug regimen, defined at the drug level over the 90-day period following receipt of PGx test results		90 days	No
Secondary	Binary occurrence of meaningful change in drug regimen, defined at the gene level over the 90-day period following receipt of PGx test results		90 days	No
Secondary	Binary occurrence of whether, in the Investigator's opinion, the subject experienced clinical benefit from drug regimen changes made as a result of the PGx test	Clinical benefit refers to improvement in the subject's condition in the Investigator's opinion	90 days	No
Secondary	Number of changes in a subject's target drugs, tabulated on a per-subject basis by number and percentage of target drugs and total drugs		90 days	No
Secondary	Binary change (yes/no) in the regimen of drugs controlled by genes of interest over the 90-day period preceding PGx testing compared with the change (yes/no) over the 90-day period following receipt of PGx test results		90 days	No
Secondary	Number of target drug-related adverse events over the 90-day period prior to and following PGx testing		90 days	No
Secondary	Emergency department visits over the 90-day periods prior to and following PGx testing		90 days	No
Secondary	Hospitalizations over the 90-day period prior to and following receipt of PGx test results		90 days	No