- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02920762
Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers
September 28, 2016 updated by: ER/LA Opioid REMS Program Companies (RPC)
A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA opioids
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
A study will be performed to evaluate changes in prescribing behavior of prescribers.
- For products that are indicated for use in opioid-tolerant patients only (i.e., fentanyl transdermal patches, extended-release hydromorphone pills and extended-release morphine pills >90mg), describe trends in the proportion of prescriptions for these products to opioid-non-tolerant patients in the year preceding the availability of REMS-compliant CE courses and compare the proportion of prescriptions to opioid non-tolerant patients pre- versus post-REMS CE course availability
- For products whose labels indicate that higher dosage strengths should only be used in opioid-tolerant patients, describe trends in the proportion of prescriptions prescribed to opioid non-tolerant patients with a high starting dosage strength; compare the proportion of prescriptions for such products that are prescribed to opioid non-tolerant patients with a high starting dosage strength pre- versus post-REMS CE course availability
- Describe trends in the proportion of prescriptions for ER/LA opioids prescribed to patients that have early refills of prescriptions and compare this proportion pre- versus post-REMS CE course availability.
- Compare the concomitant use of benzodiazepines with ER/LA opioids before and after REMS implementation.
Study Type
Observational
Enrollment (Anticipated)
5575834
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 indicated for opioid-tolerant patients, filling prescriptions early and determining concomitant use of products as gathered from the IMS National prescription Audit™ and IMS Health, LifeLink™
Description
Inclusion Criteria:
- Subjects filling a prescription for a product of interest during the specified time period will be included.
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 |
---|---|
Buprenorphine
|
|
Fentanyl
|
|
Hydromorphone HCl
|
|
Morphine Sulfate
|
|
Morphine Sulfate Beads
|
|
Oxycodone HCl
|
|
Oxymorphone HCl
|
|
Tapentadol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Monthly volume of opioid-tolerant patients prescribed products indicated for use only in opioid-tolerant patients
Time Frame: Monthly over 54 months
|
Monthly over 54 months
|
Monthly volume of opioid non-tolerant patients prescribed products indicated for use only in opioid-tolerant patients
Time Frame: Monthly over 54 months
|
Monthly over 54 months
|
Monthly volume of high-starting dose prescriptions in opioid-tolerant patients
Time Frame: Monthly over 54 months
|
Monthly over 54 months
|
Monthly volume of high starting dose prescriptions in non-opioid tolerant patients
Time Frame: Monthly over 54 months
|
Monthly over 54 months
|
Proportion of opioid non-tolerant patients that have high-starting dose prescriptions
Time Frame: Monthly over 54 months
|
Monthly over 54 months
|
Volume of early refills by monthly patient cohort
Time Frame: Monthly over 54 months
|
Monthly over 54 months
|
Volume of normal refills (non-early refills) by monthly patient cohort
Time Frame: Monthly over 54 months
|
Monthly over 54 months
|
Proportion of patients receiving early refills
Time Frame: Monthly over 54 months
|
Monthly over 54 months
|
Early refill rate by monthly patient cohort
Time Frame: Monthly over 54 months
|
Monthly over 54 months
|
Monthly volume of patients who are using a REMS product and a Benzodiazepine concomitantly
Time Frame: Monthly over 54 months
|
Monthly over 54 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 7
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.
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