Risk of Shopping Behavior of Tapentadol Immediate-Release (IR) Compared to Oxycodone Immediate-Release (IR)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Risk of Shopping Behavior of Tapentadol IR Immediate-Release (IR) Compared to Oxycodone IR Immediate-Release (IR)|
- 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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Time to first episode of shopping behavior [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- The number of shopping episodes during the year of follow up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- The type of dispensing in the first episode of shopping event [ Time Frame: 12 months ] [ Designated as safety issue: No ]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".
|Study Start Date:||February 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Drug: Tapentadol IR
Opioid naive patients exposed to tapentadol IR from July 2009 to December 2010.
Drug: Oxycodone IR
Opioid naive patients exposed to Oxycodone IR from July 2009 to December 2010.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545778
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|