An observational study in Opioid Related Disorders, Opiate Addiction and Narcotic Abuse, sponsored by ER/LA Opioid REMS Program Companies (RPC). Status unknown. Open to participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2016-10-06.
Sponsored by ER/LA Opioid REMS Program Companies (RPC) · Observational
A drug utilization study will be performed to describe trends in the number of prescriptions and patients for class REMS ER/LA opioids and comparator products.
A drug utilization study will be performed to describe trends in the number of prescriptions and patients for class REMS ER/LA opioids and comparator products.
The specific objectives of the Drug Utilization Study are:
To compare the trends in prescribing, both number of prescriptions and patients, by prescriber specialty
These trends and changes over time will be estimated for the following groups of opioids:
Comparator products/classes
1,439 studies on the registry are indexed under Opioid-Related Disorders; 291 are open to participants now.
This study's planned enrollment of 5,575,834 is above the median of 129 across 175 observational studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →ER/LA Opioid REMS Program Companies (RPC) is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects filling a prescription for a product of interest as gathered from the IMS National prescription Audit™ and IMS Health, LifeLink™
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: Non-interventional study - retrospective database review
Other: Non-interventional study - retrospective database review
Other: Non-interventional study - retrospective database review
Other: Non-interventional study - retrospective database review
Number of opioid prescriptions filled
Time frame: Monthly over 54 months
Compare average number of prescriptions per time period in the 2 years before as compared to the same measure in implementation and active periods
Time frame: Pre REMS Implementation (July 10-June 12)
Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty
Time frame: Pre REMS Implementation (July 10-June 12)
Number and Rate of Switches from ER/ LA opioids to comparator analgesics with introduction of REMS
Time frame: Monthly over 54 months
Compare average number of prescriptions per time period in the 2 years before as compared to the same measure in implementation and active periods
Time frame: Implementation (July 12-June 13)
Compare average number of prescriptions per time period in the 2 years before as compared to the same measure in implementation and active periods
Time frame: Active Period (July 13-Dec 14)
Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty
Time frame: Implementation (July 12-June 13)
Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty
Time frame: Active Period (July 13-Dec 14)
No study locations are listed for this record.
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ER/LA Opioid REMS Program Companies (RPC)