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| ID | Type | Description | Link |
|---|---|---|---|
| RRA-5950 | Other Identifier | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tapentadol IR |
| ||
| Oxycodone IR |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tapentadol IR | Drug | Opioid naive patients exposed to tapentadol IR from July 2009 to December 2010. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Opioid naive patients exposed to tapentadol IR or oxycodone IR from July 2009 to December 2010 who did not fill any other opioid prescription within 4 days on or after the index date. The index date is the date of the first prescription for tapentadol IR or oxycodone IR after June 30, 2009. A naive patient is a patient who has not received an opioid of any type in the 3 months before the index date.
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23253635 | Derived | Cepeda MS, Fife D, Vo L, Mastrogiovanni G, Yuan Y. Comparison of opioid doctor shopping for tapentadol and oxycodone: a cohort study. J Pain. 2013 Feb;14(2):158-64. doi: 10.1016/j.jpain.2012.10.012. Epub 2012 Dec 17. |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Oxycodone IR | Drug | Opioid naive patients exposed to Oxycodone IR from July 2009 to December 2010. |
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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 |