Evaluation of Drug Utilization Patterns for Extended Release/Long Acting Opioids and Comparator Products
NCT ID: NCT02925806
Last Updated: 2016-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
5575834 participants
OBSERVATIONAL
Brief Summary
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Detailed Description
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The specific objectives of the Drug Utilization Study are:
1. To estimate trends by month in the number of prescriptions for a one-year period before, and each month after, the implementation of the REMS
2. To compare average number of prescriptions per 3 month (quarter) period in the 2 years before as compared to the same measure during Implementation and the Active Period
3. To evaluate change by patient characteristics (age group, gender, pay type, prescriber specialty)
4. 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:
* ER/LA opioids included in the class REMS
* Comparator products/classes
* Immediate release (IR) opioids
* Celecoxib
* Benzodiazepines
5. To show switches (absolute and rates of switching) from ER/LA opioids to comparator analgesics (IR opioids or celecoxib) with introduction of REMS
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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ER/LA opioids included in the class REMS
Non-interventional study - retrospective database review
IR Opioids
Non-interventional study - retrospective database review
Celecoxib
Non-interventional study - retrospective database review
Benzodiazepines
Non-interventional study - retrospective database review
Interventions
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Non-interventional study - retrospective database review
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
100 Years
ALL
No
Sponsors
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ER/LA Opioid REMS Program Companies (RPC)
INDUSTRY
Responsible Party
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Other Identifiers
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Assessment 6
Identifier Type: -
Identifier Source: org_study_id
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