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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02095769
Other study ID # 201301
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT01970709 - Diagnosing Adverse Drug Reactions Registry N/A
Recruiting NCT02081872 - Utility of PharmacoGenomics for Reducing Adverse Drug Effects N/A