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

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ClinicalTrials.gov Identifier: NCT02866266
Recruitment Status : Unknown
Verified October 2016 by ER/LA Opioid REMS Program Companies (RPC).
Recruitment status was:  Active, not recruiting
First Posted : August 15, 2016
Last Update Posted : October 5, 2016
Sponsor:
Collaborator:
HealthCore, Inc.
Information provided by (Responsible Party):
ER/LA Opioid REMS Program Companies (RPC)

Tracking Information
First Submitted Date June 8, 2016
First Posted Date August 15, 2016
Last Update Posted Date October 5, 2016
Study Start Date Not Provided
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 4, 2016)
  • 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 ]
Original Primary Outcome Measures
 (submitted: August 10, 2016)
Number of ED visits and hospitalizations for opioid overdose/poisoning and mortality [ Time Frame: Retrospective review over period from July 2010 through December 2014 ]
Change History
Current Secondary Outcome Measures
 (submitted: August 10, 2016)
All-cause mortality [ Time Frame: Retrospective review over period from July 2010 through December 2014 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning
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
Brief 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.
Detailed 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients that receive at least one dispensing of an ER/LA opioid during at least one study REMS period with at least six months of prior continuous health plan eligibility in the main analyses. Additional analyses will consider patients enrolled in the HIRD or a participating Medicaid plan regardless of ER/LA opioid exposure.
Condition
  • Opioid-related Disorders
  • Opioid Addiction
  • Narcotic Abuse
  • Drug Abuse
Intervention Other: Retrospective database review
Study Groups/Cohorts
  • All commercially insured patients in the HIRD
    Intervention: Other: Retrospective database review
  • All Medicaid patients in a participating state Medicaid plan
    Intervention: Other: Retrospective database review
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: August 10, 2016)
183452
Original Actual Enrollment Same as current
Study Completion Date Not Provided
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02866266
Other Study ID Numbers Assessment 5.1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ER/LA Opioid REMS Program Companies (RPC)
Study Sponsor ER/LA Opioid REMS Program Companies (RPC)
Collaborators HealthCore, Inc.
Investigators Not Provided
PRS Account ER/LA Opioid REMS Program Companies (RPC)
Verification Date October 2016