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Monitoring Patterns of Prescribing to Identify Changes in Access to ER/LA Opioid Analgesics

NCT ID: NCT02920775

Last Updated: 2016-09-30

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

360000 participants

Study Classification

OBSERVATIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Related Disorders Opiate Addiction Narcotic Abuse Drug Abuse

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pain

Non-interventional study - retrospective database review

Intervention Type OTHER

PCP

Non-interventional study - retrospective database review

Intervention Type OTHER

Dentist

Non-interventional study - retrospective database review

Intervention Type OTHER

Surgery

Non-interventional study - retrospective database review

Intervention Type OTHER

Emergency Medicine

Non-interventional study - retrospective database review

Intervention Type OTHER

Oncology

Non-interventional study - retrospective database review

Intervention Type OTHER

Hospice and Palliative Medicine

Non-interventional study - retrospective database review

Intervention Type OTHER

Anesthesiology

Non-interventional study - retrospective database review

Intervention Type OTHER

Neurology

Non-interventional study - retrospective database review

Intervention Type OTHER

Nurse Practitioners

Non-interventional study - retrospective database review

Intervention Type OTHER

Pediatrics

Non-interventional study - retrospective database review

Intervention Type OTHER

Physical Medicine & Rehabilitation

Non-interventional study - retrospective database review

Intervention Type OTHER

Physician Assistant

Non-interventional study - retrospective database review

Intervention Type OTHER

Rheumatology

Non-interventional study - retrospective database review

Intervention Type OTHER

All Other Specialties

Non-interventional study - retrospective database review

Intervention Type OTHER

Interventions

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Non-interventional study - retrospective database review

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Changes in number of prescriptions for prescriber types with less or more compelling reasons to prescriber ER/LA opioid analgesics

Exclusion Criteria

* None
Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ER/LA Opioid REMS Program Companies (RPC)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Assessment 8

Identifier Type: -

Identifier Source: org_study_id