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NCT02925806 Clinical Trial

Evaluation of Drug Utilization Patterns for Extended Release/Long Acting Opioids and Comparator Products

Drug Abuse Clinical Trial

Official title:
Drug Utilization Study of Trends in Prescriptions for Class REMS ER/LA Opioids and Comparator Products; Evaluation of Drug Utilization Patterns

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02925806
Other study ID # Assessment 6
Secondary ID
Status Enrolling by invitation
Phase N/A
First received September 28, 2016
Last updated October 4, 2016

Study information
Verified date October 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

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.

Description:

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.

The specific objectives of the Drug Utilization Study are:

1. To estimate trends by month in the number of prescriptions for a one-year period before, and each month after, the implementation of the REMS

2. To compare average number of prescriptions per 3 month (quarter) period in the 2 years before as compared to the same measure during Implementation and the Active Period

3. To evaluate change by patient characteristics (age group, gender, pay type, prescriber specialty)

4. To compare the trends in prescribing, both number of prescriptions and patients, by prescriber specialty

These trends and changes over time will be estimated for the following groups of opioids:

- ER/LA opioids included in the class REMS

- Comparator products/classes

- Immediate release (IR) opioids

- Celecoxib

- Benzodiazepines

5. To show switches (absolute and rates of switching) from ER/LA opioids to comparator analgesics (IR opioids or celecoxib) with introduction of REMS

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 5575834
Est. completion date
Est. primary completion date July 2019
Accepts healthy volunteers
Gender Both
Age group N/A to 100 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, 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 Number of opioid prescriptions filled Monthly over 54 months
Primary 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)
Primary Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty Pre REMS Implementation (July 10-June 12)
Primary Number and Rate of Switches from ER/ LA opioids to comparator analgesics with introduction of REMS Monthly over 54 months
Primary 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)
Primary 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)
Primary Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty Implementation (July 12-June 13)
Primary Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty Active Period (July 13-Dec 14)
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