NCT02920775

Brief 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). Trends and changes in monthly prescription volume and average monthly prescription volume will be evaluated by prescriber specialty.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360,000

participants targeted

Target at P75+ for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

First QC Date

September 28, 2016

Last Update Submit

September 28, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Monthly volume of prescriptions by specialty

    July 2010-December 2014

Study Arms (15)

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

Interventions

All Other SpecialtiesAnesthesiologyDentistEmergency MedicineHospice and Palliative MedicineNeurologyNurse PractitionersOncologyPCPPainPediatricsPhysical Medicine & RehabilitationPhysician AssistantRheumatologySurgery

Eligibility Criteria

AgeUp to 100 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects filling a prescription for a product of interest as gathered from the IMS National prescription Audit™ and IMS Health, LifeLink™

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Opioid-Related DisordersNarcotic-Related DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2016

First Posted

September 30, 2016

Primary Completion

July 1, 2019

Last Updated

September 30, 2016

Record last verified: 2016-09