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
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 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.
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
ER/LA Opioid REMS Program Companies (RPC) | HealthCore, Inc. |
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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