Opioid Related DisordersNCT02920775
Monitoring Patterns of Prescribing to Identify Changes in Access to ER/LA Opioid Analgesics
An observational study of Opioid Related Disorders and Opiate Addiction, run by ER/LA Opioid REMS Program Companies (RPC).
Trial summary
Changes in prescribing will be compared in prescribers from specialties whose prescribing is hypothesized to be relatively unaffected by the REMS (such as oncologists and hospice providers) versus those for whom the REMS could have greater impact on prescribing (e.g., dentists). 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
- 360,000 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
- Changes in number of prescriptions for prescriber types with less or more compelling reasons to prescriber ER/LA opioid analgesics
Who cannot join
- None
About this study
Changes in prescribing will be compared in prescribers from specialties whose prescribing is hypothesized to be relatively unaffected by the REMS (such as oncologists and hospice providers) versus those for whom the REMS could have greater impact on prescribing (e.g., dentists). Trends and changes in monthly prescription volume and average monthly prescription volume will be evaluated by prescriber specialty.
- 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 |
|---|---|---|
| Pain | Not described Receives: Other: Non-interventional study - retrospective database review | |
| PCP | Not described Receives: Other: Non-interventional study - retrospective database review | |
| Dentist | Not described Receives: Other: Non-interventional study - retrospective database review | |
| Surgery | Not described Receives: Other: Non-interventional study - retrospective database review | |
| Emergency Medicine | Not described Receives: Other: Non-interventional study - retrospective database review | |
| Oncology | Not described Receives: Other: Non-interventional study - retrospective database review | |
| Hospice and Palliative Medicine | Not described Receives: Other: Non-interventional study - retrospective database review | |
| Anesthesiology | Not described Receives: Other: Non-interventional study - retrospective database review | |
| Neurology | Not described Receives: Other: Non-interventional study - retrospective database review | |
| Nurse Practitioners | Not described Receives: Other: Non-interventional study - retrospective database review | |
| Pediatrics | Not described Receives: Other: Non-interventional study - retrospective database review | |
| Physical Medicine & Rehabilitation | Not described Receives: Other: Non-interventional study - retrospective database review | |
| Physician Assistant | Not described Receives: Other: Non-interventional study - retrospective database review | |
| Rheumatology | Not described Receives: Other: Non-interventional study - retrospective database review | |
| All Other Specialties | 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.
Monthly volume of prescriptions by specialty
Measured: July 2010-December 2014
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 360,000 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
- NCT02920775
- Sponsor's protocol ID
- Assessment 8
- 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
- Monitoring Patterns of Prescribing to Identify Changes in Access to ER/LA Opioid Analgesics
- ClinicalTrials.gov ID
- NCT02920775
- Acronym / sponsor ID
- Assessment 8
- Conditions
- Opioid Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360,000 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.
Changes in prescribing will be compared in prescribers from specialties whose prescribing is hypothesized to be relatively unaffected by the REMS (such as oncologists and hospice providers) versus those for whom the REMS could have greater impact on prescribing (e.g., dentists). Trends and changes in monthly prescription volume and average monthly prescription volume will be evaluated by prescriber specialty.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Pain | – | Other: Non-interventional study - retrospective database review |
| PCP | – | Other: Non-interventional study - retrospective database review |
| Dentist | – | Other: Non-interventional study - retrospective database review |
| Surgery | – | Other: Non-interventional study - retrospective database review |
| Emergency Medicine | – | Other: Non-interventional study - retrospective database review |
| Oncology | – | Other: Non-interventional study - retrospective database review |
| Hospice and Palliative Medicine | – | Other: Non-interventional study - retrospective database review |
| Anesthesiology | – | Other: Non-interventional study - retrospective database review |
| Neurology | – | Other: Non-interventional study - retrospective database review |
| Nurse Practitioners | – | Other: Non-interventional study - retrospective database review |
| Pediatrics | – | Other: Non-interventional study - retrospective database review |
| Physical Medicine & Rehabilitation | – | Other: Non-interventional study - retrospective database review |
| Physician Assistant | – | Other: Non-interventional study - retrospective database review |
| Rheumatology | – | Other: Non-interventional study - retrospective database review |
| All Other Specialties | – | 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)
- Changes in number of prescriptions for prescriber types with less or more compelling reasons to prescriber ER/LA opioid analgesics
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 | All Other Specialties, Anesthesiology, Dentist, Emergency Medicine, Hospice and Palliative Medicine, Neurology, Nurse Practitioners, Oncology, PCP, Pain, Pediatrics, Physical Medicine & Rehabilitation, Physician Assistant, Rheumatology, Surgery |
Primary outcome
Monthly volume of prescriptions by specialty
Time frame: July 2010-December 2014
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 prescriptions by specialty (time frame: July 2010-December 2014). 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.