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NCT02920775 Clinical Trial

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

Drug Abuse Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02920775
Other study ID # Assessment 8
Secondary ID
Status Enrolling by invitation
Phase N/A
First received September 28, 2016
Last updated September 28, 2016

Study information
Verified date September 2016
Source ER/LA Opioid REMS Program Companies (RPC)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 360000
Est. completion date
Est. primary completion date July 2019
Accepts healthy volunteers
Gender Both
Age group N/A to 100 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• Non-interventional study - retrospective database review

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
ER/LA Opioid REMS Program Companies (RPC)

Outcome
Type Measure Description Time frame Safety issue
Primary Monthly volume of prescriptions by specialty July 2010-December 2014
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