Opioid-related Disorders Clinical Trial
Official title:
Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS): RADARS® System Surveillance Protocol
NCT number | NCT02871232 |
Other study ID # | Assessments 5.2-5.4 |
Secondary ID | |
Status | Enrolling by invitation |
Phase | N/A |
First received | August 15, 2016 |
Last updated | August 24, 2016 |
To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics. Briefly, therefore, the overall surveillance objective is to evaluate for trends before and after the shared REMS is implemented to collectively assess for changes in abuse, misuse, overdose, addiction, and death for different risk groups and settings.
Status | Enrolling by invitation |
Enrollment | 26500 |
Est. completion date | |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Any patient with data in the RADARS system Exclusion Criteria: |
Observational Model: Cohort
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
ER/LA Opioid REMS Program Companies (RPC) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Poisson regression will be used to compare changes in rates of abuse, misuse, overdose, and death and other outcomes over time within the ER/LA opioid group to changes in rates among the comparator groups | Review over period from January 2010 to December 2016 | ||
Secondary | Mean number of dosing units per prescriptions dispensed across time for the ER/LA REMS drug group | Review over period from January 2010 to December 2016 |
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