Monitoring Patterns of Prescribing to Identify Changes in Access to ER/LA Opioid Analgesics

September 28, 2016 updated by: ER/LA Opioid REMS Program Companies (RPC)
Changes in prescribing will be compared in prescribers from specialties whose prescribing is hypothesized to be relatively unaffected by the REMS (such as oncologists and hospice providers) versus those for whom the REMS could have greater impact on prescribing (e.g., dentists). Trends and changes in monthly prescription volume and average monthly prescription volume will be evaluated by prescriber specialty.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

360000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects filling a prescription for a product of interest as gathered from the IMS National prescription Audit™ and IMS Health, LifeLink™

Description

Inclusion Criteria:

  • Changes in number of prescriptions for prescriber types with less or more compelling reasons to prescriber ER/LA opioid analgesics

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pediatrics
Other: Non-interventional study - retrospective database review
Surgery
Other: Non-interventional study - retrospective database review
Pain
Other: Non-interventional study - retrospective database review
PCP
Other: Non-interventional study - retrospective database review
Dentist
Other: Non-interventional study - retrospective database review
Emergency Medicine
Other: Non-interventional study - retrospective database review
Oncology
Other: Non-interventional study - retrospective database review
Hospice and Palliative Medicine
Other: Non-interventional study - retrospective database review
Anesthesiology
Other: Non-interventional study - retrospective database review
Neurology
Other: Non-interventional study - retrospective database review
Nurse Practitioners
Other: Non-interventional study - retrospective database review
Physical Medicine & Rehabilitation
Other: Non-interventional study - retrospective database review
Physician Assistant
Other: Non-interventional study - retrospective database review
Rheumatology
Other: Non-interventional study - retrospective database review
All Other Specialties
Other: Non-interventional study - retrospective database review

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Monthly volume of prescriptions by specialty
Time Frame: July 2010-December 2014
July 2010-December 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ER/LA Opioid REMS Program Companies (RPC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

September 28, 2016

First Posted (Estimate)

September 30, 2016

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Assessment 8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Drug Abuse

Clinical Trials on Non-interventional study - retrospective database review

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe