Overview

This trial is active, not recruiting.

Conditions opioid-related disorders, opioid addiction, narcotic abuse, drug abuse
Treatment retrospective database review
Sponsor ER/LA Opioid REMS Program Companies (RPC)
Collaborator HealthCore, Inc.
End date October 2015
Trial size 183452 participants
Trial identifier NCT02866266, Assessment 5.1

Summary

Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency Department visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
retrospective database review
retrospective database review

Primary Outcomes

Measure
Number of ED visits for opioid overdose/poisoning and mortality
time frame: Retrospective review over period from July 2010 through December 2014
Number of hospitalizations for opioid overdose/poisoning and mortality
time frame: Retrospective review over period from July 2010 through December 2014

Secondary Outcomes

Measure
All-cause mortality
time frame: Retrospective review over period from July 2010 through December 2014

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: 1. At least one dispensing of an ER/LA opioid after 01 July 2010 2. At least six months of continuous health plan eligibility prior to the first recorded dispensing of an opioid that occurs during an included REMS period Exclusion Criteria: 1. Missing or implausible values for age 2. Missing or implausible values for gender

Additional Information

Official title Extended Release (ER) / Long-acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) Assessment 5.1: Surveillance of Emergency Department Visits and Hospitalizations for Opioid Overdose and Poisoning Events
Description As part of the FDA-approved plan to evaluate the effects of the REMS program, the REMS Program Companies (RPC) are required to submit FDA assessment reports on a regular basis. The present study is one of several program evaluation components carried out in support Assessment 5: Surveillance monitoring for misuse, abuse, overdose, addiction, death and intervention taken. This study will evaluate the impact of the ER/LA opioid REMS program on the incidence of ED visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by ER/LA Opioid REMS Program Companies (RPC).