Risk of Shopping Behavior of Tapentadol Immediate-Release (IR) Compared to Oxycodone Immediate-Release (IR)

Substance Abuse Detection Clinical Trial

Official title:

Risk of Shopping Behavior of Tapentadol IR Immediate-Release (IR) Compared to Oxycodone IR Immediate-Release (IR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545778
• Other study ID #: CR100822
• Secondary ID: RRA-5950
• Status: Completed
• Phase: N/A
• First received: February 28, 2012
• Last updated: October 26, 2012
• Start date: February 2010
• Est. completion date: February 2012

Study information

• Verified date: October 2012
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: None due to the nature of the study (Registry)
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to compare the risk of shopping behavior of tapentadol immediate release with the risk of shopping behavior of oxycodone immediate release.

Description:

This is a retrospective (a study that looks backward in time, usually using medical records and interviews with patients) matched cohort (designated group followed or traced over a period of time) study using IMS LRx database. This database covers 65% of all retail prescriptions in the United States and includes mail service and specialty pharmacy provider prescriptions independent of the method of payment. The study will include Opioid naive patients exposed to tapentadol immediate release (IR) or oxycodone IR from July 2009 to December 2010. A naive patient is a patient who has not received an opioid of any type in the 3 months before the index date. The index date is the date of the first prescription for tapentadol IR or oxycodone IR after June 30, 2009. Patients will be followed for 1 year from their index dates. Each tapentadol IR-exposed patient will be matched to up to 4 oxycodone IR-exposed patients. Matching will allow to control in the design for potential confounding variables such as time of the exposure, geographic area, specialty of the prescriber, and age. These are variables that have been related with the risk of shopping behavior or abuse.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 646620
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Opioid naive patients (a patient who has not received an opioid of any type in the 3 months before the index date) exposed to tapentadol IR or oxycodone IR from July 2009 to December 2010 [The index date is the date of the first prescription for tapentadol IR or oxycodone IR after June 30, 2009]

Exclusion Criteria:

• Patients with use of any opioid 3 months before the index date

• Patients who within 4 days on or after the index date fill a prescription for a different opioid

• Patients who within 4 days on or after the index date fill a prescription for the same opioid but written by a different prescriber

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Substance Abuse Detection

Intervention

Drug:
• Tapentadol IR
Opioid naive patients exposed to tapentadol IR from July 2009 to December 2010.
• Oxycodone IR
Opioid naive patients exposed to Oxycodone IR from July 2009 to December 2010.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who developed shopping behavior defined as patients with prescriptions with at least one day of overlap, written by = 2 different prescribers and filled in 3 or more pharmacies		12 months	No
Secondary	Time to first episode of shopping behavior		12 months	No
Secondary	The number of shopping episodes during the year of follow up		12 months	No
Secondary	The type of dispensing in the first episode of shopping event	The type of dispensing in the shopping event will be classified as "Only the indexed opioid" "Indexed opioid was involved", or "Indexed opioid was not involved at all".	12 months	No