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

Completed

• Conditions: Substance Abuse Detection
• Interventions: Drug: Oxycodone IR; Drug: Tapentadol IR

• Registration Number: NCT01545778
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-07
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-26
• Last Update Posted: 2012-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 646620

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oxycodone IR	Oxycodone IR	-
Tapentadol IR	Tapentadol IR	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Time to first episode of shopping behavior	12 months
The number of shopping episodes during the year of follow up	12 months
The type of dispensing in the first episode of shopping event	12 months	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".