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NCT02866266 Clinical Trial

ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning

Opioid-related Disorders Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02866266
Other study ID # Assessment 5.1
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 8, 2016
Last updated October 4, 2016

Study information
Verified date October 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

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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 183452
Est. completion date
Est. primary completion date October 2015
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• Retrospective database review

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
ER/LA Opioid REMS Program Companies (RPC) HealthCore, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Number of ED visits for opioid overdose/poisoning and mortality Retrospective review over period from July 2010 through December 2014
Primary Number of hospitalizations for opioid overdose/poisoning and mortality Retrospective review over period from July 2010 through December 2014
Secondary All-cause mortality Retrospective review over period from July 2010 through December 2014
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