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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

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

Study information

Verified date August 2016
Source ER/LA Opioid REMS Program Companies (RPC)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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:

Study Design

Observational Model: Cohort


Intervention

Other:
Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
ER/LA Opioid REMS Program Companies (RPC)

Outcome

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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