Opioid Related DisordersNCT02925806
Evaluation of Drug Utilization Patterns for Extended Release/Long Acting Opioids and Comparator Products
An observational study of Opioid Related Disorders and Opiate Addiction, run by ER/LA Opioid REMS Program Companies (RPC).
Trial summary
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. 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?
- Non-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 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
Official title: Drug Utilization Study of Trends in Prescriptions for Class REMS ER/LA Opioids and Comparator Products; Evaluation of Drug Utilization Patterns
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.
Read the detailed description
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 estimate trends by month in the number of prescriptions for a one-year period before, and each month after, the implementation of the REMS
- 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
- To evaluate change by patient characteristics (age group, gender, pay type, prescriber specialty)
- 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
- To show switches (absolute and rates of switching) from ER/LA opioids to comparator analgesics (IR opioids or celecoxib) with introduction of REMS
- Conditions
- Opioid Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Being tested
- Non-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.
Non-interventional study - retrospective database reviewOther
| Study group | Role | What they receive |
|---|---|---|
| ER/LA opioids included in the class REMS | Not described Receives: Other: Non-interventional study - retrospective database review | |
| IR Opioids | Not described Receives: Other: Non-interventional study - retrospective database review | |
| Celecoxib | Not described Receives: Other: Non-interventional study - retrospective database review | |
| Benzodiazepines | Not described Receives: Other: Non-interventional study - retrospective database review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of opioid prescriptions filled
Measured: 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
Measured: Pre REMS Implementation (July 10-June 12)
Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty
Measured: Pre REMS Implementation (July 10-June 12)
Number and Rate of Switches from ER/ LA opioids to comparator analgesics with introduction of REMS
Measured: 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
Measured: 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
Measured: Active Period (July 13-Dec 14)
Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty
Measured: Implementation (July 12-June 13)
Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty
Measured: Active Period (July 13-Dec 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 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
- NCT02925806
- Sponsor's protocol ID
- Assessment 6
- Status last verified
- Oct 2016
- First submitted
- 28 Sep 2016
- Last updated
- 6 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Utilization Study of Trends in Prescriptions for Class REMS ER/LA Opioids and Comparator Products; Evaluation of Drug Utilization Patterns
- ClinicalTrials.gov ID
- NCT02925806
- Acronym / sponsor ID
- Assessment 6
- 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
- 6 Oct 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 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.
Detailed description
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 estimate trends by month in the number of prescriptions for a one-year period before, and each month after, the implementation of the REMS
- 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
- To evaluate change by patient characteristics (age group, gender, pay type, prescriber specialty)
- 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
- To show switches (absolute and rates of switching) from ER/LA opioids to comparator analgesics (IR opioids or celecoxib) with introduction of REMS
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ER/LA opioids included in the class REMS | – | Other: Non-interventional study - retrospective database review |
| IR Opioids | – | Other: Non-interventional study - retrospective database review |
| Celecoxib | – | Other: Non-interventional study - retrospective database review |
| Benzodiazepines | – | Other: Non-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 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 |
|---|---|---|
| Non-interventional study - retrospective database review | Other | Benzodiazepines, Celecoxib, ER/LA opioids included in the class REMS, IR Opioids |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 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 6 Oct 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?
Number of opioid prescriptions filled (time frame: Monthly over 54 months). The study lists 8 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 6 Oct 2016.