NCT02925806

Brief 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.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
5,575,834

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Last Updated

October 6, 2016

Status Verified

October 1, 2016

First QC Date

September 28, 2016

Last Update Submit

October 4, 2016

Conditions

Opioid Related DisordersOpiate AddictionNarcotic AbuseDrug Abuse

Outcome Measures

Primary Outcomes (8)

  • Number of opioid prescriptions filled

    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

    Pre REMS Implementation (July 10-June 12)

  • Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty

    Pre REMS Implementation (July 10-June 12)

  • Number and Rate of Switches from ER/ LA opioids to comparator analgesics with introduction of REMS

    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

    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

    Active Period (July 13-Dec 14)

  • Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty

    Implementation (July 12-June 13)

  • Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty

    Active Period (July 13-Dec 14)

Study Arms (4)

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

Interventions

Non-interventional study - retrospective database reviewOTHER
BenzodiazepinesCelecoxibER/LA opioids included in the class REMSIR Opioids

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:

  • Subjects filling a prescription for a product of interest during the specified time period will be included.

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
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2016

First Posted

October 6, 2016

Primary Completion

July 1, 2019

Last Updated

October 6, 2016

Record last verified: 2016-10