Risk of Shopping Behavior of Tapentadol Immediate-Release (IR) Compared to Oxycodone Immediate-Release (IR)
| Tracking Information | |||||
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| First Received Date ICMJE | February 28, 2012 | ||||
| Last Updated Date | October 26, 2012 | ||||
| Start Date ICMJE | February 2010 | ||||
| Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01545778 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Risk of Shopping Behavior of Tapentadol Immediate-Release (IR) Compared to Oxycodone Immediate-Release (IR) | ||||
| Official Title ICMJE | Risk of Shopping Behavior of Tapentadol IR Immediate-Release (IR) Compared to Oxycodone IR Immediate-Release (IR) | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | 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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| Condition ICMJE | Substance Abuse Detection | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * | 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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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 646620 | ||||
| Completion Date | February 2012 | ||||
| Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01545778 | ||||
| Other Study ID Numbers ICMJE | CR100822, RRA-5950 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | VICE PRESIDENT EPIDEMIOLOGY, Janssen R&D US | ||||
| Study Sponsor ICMJE | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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