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ER/LA Opioid Analgesics - Surveillance Monitoring of State Medical Examiner Databases

NCT02897414 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 13015

Last updated 2016-09-13

No results posted yet for this study

Summary

In April 2011, the U.S. Food and Drug Administration (FDA) determined that a class-wide risk evaluation and mitigation strategy (REMS) for all extended-release (ER) and long-acting (LA) opioid medications was necessary to support national efforts to reduce serious adverse outcomes resulting from opioid abuse. This study will evaluate trends before and after the ER/LA REMS implementation for changes in mortality rates associated with prescription opioids utilizing state medical examiner databases from multiple states. Databases from 2005 through the most recent year available will be obtained.

Conditions

Interventions

OTHER

Surveillance of state medical examiner databases

Sponsors & Collaborators

  • ER/LA Opioid REMS Program Companies (RPC)

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2016-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02897414 on ClinicalTrials.gov