Drug Side Effects Clinical Trial
— PREACTOfficial title:
Pharmacogenomics Registry to Assess Clinical Utility
| NCT number | NCT02374840 |
| Other study ID # | CD-2014-102 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | N/A |
| First received | February 24, 2015 |
| Last updated | July 20, 2015 |
The PREACT Registry aims to see whether data from Pharmacogenomic Testing (PGx) can help
healthcare providers manage patient medication regimens and assess if the testing has an
effect on reducing medication side effects, hospitalizations and emergency department
visits.
The way an individual processes a drug is in part determined by their genes, and there is
known to be genetic variation between humans in the way drugs are metabolized. The study of
the way genes affect a person's response to drugs is known as "Pharmacogenomics."
| Status | Not yet recruiting |
| Enrollment | 340778 |
| Est. completion date | |
| Est. primary completion date | February 2019 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years and older |
| Eligibility |
Inclusion Criteria: - Pharmacogenomic testing has been performed within 12-months prior to eligibility assessment for genes known to influence metabolism of at least one target drug - Subject is 2 years of age or older - Subject is not taking an investigational medication or in a clinical trial that would interfere with participation in the registry Exclusion Criteria: - Subject's medical and medication history is unavailable over the 90-day period preceding the receipt of pharmacogenomic test results - Subject (or subject's parent/guardian) is unable to provide an accurate history due to mental incapacity, in the Investigator's opinion. |
Observational Model: Cohort
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Companion Dx Reference Lab, LLC |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Meaningful Change | Binary occurrence of meaningful change in drug regimen, defined for each subject as: A genotype known to affect a target drug is identified by pharmacogenomic testing, and The treating physician makes at least one target drug regimen change in dose, frequency, route of administration, drug discontinuation, addition or substitution. |
90 day | No |
| Secondary | Changes in target drug regimen | Changes in target drug regimen over the 90-day period preceding receipt of PGx results, compared to the changes made in the 90-day period thereafter. | 90 days retrospective; 90 days prospective | No |
| Secondary | Number of target drug adverse events (TDAE) | Number of TDAE over the 90-day period preceding receipt of pharmacogenomics test results compared with the number over the 90-day period after the test | 90 day retrospective; 90 day prospective | No |
| Secondary | Target drug related emergency department visits | Emergency department visits over the 90-day period prior to receipt of pharmacogenomics test results, compared to the number of visits over the 90-day period following receipt of test results. | 90 day retrospective; 90 day prospective | No |
| Secondary | Target drug related hospitalizations | Hospitalizations over the 90-day period prior to receipt of pharmacogenomics test results, compared to the number of visits over the 90-day period following receipt of test results. | 90 day retrospective; 90 day prospective | No |