Opioid Related DisordersNCT02920762
Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers
An observational study of Opioid Related Disorders and Opiate Addiction, run by ER/LA Opioid REMS Program Companies (RPC).
Trial summary
A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA opioids Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Opioid Related Disorders, Opiate Addiction, Narcotic Abuse
- What is being tested?
- on-interventional study - retrospective database review
- How many people
- 5,575,834 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- Child, Adult, Older adult
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™
Who may be able to join
- Subjects filling a prescription for a product of interest during the specified time period will be included.
Who cannot join
- None
About this study
A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA opioids
Read the 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.
- Conditions
- Opioid Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Being tested
- on-interventional study - retrospective database review
- Medical subject headings
- Opioid-Related Disorders, Narcotic-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
on-interventional study - retrospective database reviewOther
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine | Not described Receives: Other: on-interventional study - retrospective database review | |
| Fentanyl | Not described Receives: Other: on-interventional study - retrospective database review | |
| Hydromorphone HCl | Not described Receives: Other: on-interventional study - retrospective database review | |
| Morphine Sulfate | Not described Receives: Other: on-interventional study - retrospective database review | |
| Morphine Sulfate Beads | Not described Receives: Other: on-interventional study - retrospective database review | |
| Oxycodone HCl | Not described Receives: Other: on-interventional study - retrospective database review | |
| Oxymorphone HCl | Not described Receives: Other: on-interventional study - retrospective database review | |
| Tapentadol | Not described Receives: Other: on-interventional study - retrospective database review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly volume of opioid-tolerant patients prescribed products indicated for use only in opioid-tolerant patients
Measured: Monthly over 54 months
Monthly volume of opioid non-tolerant patients prescribed products indicated for use only in opioid-tolerant patients
Measured: Monthly over 54 months
Monthly volume of high-starting dose prescriptions in opioid-tolerant patients
Measured: Monthly over 54 months
Monthly volume of high starting dose prescriptions in non-opioid tolerant patients
Measured: Monthly over 54 months
Proportion of opioid non-tolerant patients that have high-starting dose prescriptions
Measured: Monthly over 54 months
Volume of early refills by monthly patient cohort
Measured: Monthly over 54 months
Volume of normal refills (non-early refills) by monthly patient cohort
Measured: Monthly over 54 months
Proportion of patients receiving early refills
Measured: Monthly over 54 months
Early refill rate by monthly patient cohort
Measured: Monthly over 54 months
Monthly volume of patients who are using a REMS product and a Benzodiazepine concomitantly
Measured: Monthly over 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Primary completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,575,834 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ER/LA Opioid REMS Program Companies (RPC)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920762
- Sponsor's protocol ID
- Assessment 7
- Status last verified
- Sep 2016
- First submitted
- 28 Sep 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers
- ClinicalTrials.gov ID
- NCT02920762
- Acronym / sponsor ID
- Assessment 7
- Conditions
- Opioid Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,575,834 participants (estimated)
- Lead sponsor
- ER/LA Opioid REMS Program Companies (RPC)Industry (pharma, biotech, devices)
- Primary completion
- Jul 2019 (estimated)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA opioids
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine | – | Other: on-interventional study - retrospective database review |
| Fentanyl | – | Other: on-interventional study - retrospective database review |
| Hydromorphone HCl | – | Other: on-interventional study - retrospective database review |
| Morphine Sulfate | – | Other: on-interventional study - retrospective database review |
| Morphine Sulfate Beads | – | Other: on-interventional study - retrospective database review |
| Oxycodone HCl | – | Other: on-interventional study - retrospective database review |
| Oxymorphone HCl | – | Other: on-interventional study - retrospective database review |
| Tapentadol | – | Other: on-interventional study - retrospective database review |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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™
Key inclusion criteria (1 listed)
- Subjects filling a prescription for a product of interest during the specified time period will be included.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| on-interventional study - retrospective database review | Other | Buprenorphine, Fentanyl, Hydromorphone HCl, Morphine Sulfate, Morphine Sulfate Beads, Oxycodone HCl, Oxymorphone HCl, Tapentadol |
Primary outcome
Monthly volume of opioid-tolerant patients prescribed products indicated for use only in opioid-tolerant patients
Time frame: 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 volume of high-starting dose prescriptions in opioid-tolerant patients
Time frame: Monthly over 54 months
Monthly volume of high starting dose prescriptions in non-opioid tolerant patients
Time frame: Monthly over 54 months
Proportion of opioid non-tolerant patients that have high-starting dose prescriptions
Time frame: Monthly over 54 months
Volume of early refills by monthly patient cohort
Time frame: Monthly over 54 months
Volume of normal refills (non-early refills) by monthly patient cohort
Time frame: Monthly over 54 months
Proportion of patients receiving early refills
Time frame: Monthly over 54 months
Early refill rate by monthly patient cohort
Time frame: Monthly over 54 months
Monthly volume of patients who are using a REMS product and a Benzodiazepine concomitantly
Time frame: Monthly over 54 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Related Disorders and Opiate Addiction, run by ER/LA Opioid REMS Program Companies (RPC).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly volume of opioid-tolerant patients prescribed products indicated for use only in opioid-tolerant patients (time frame: Monthly over 54 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.