Risk of Shopping Behavior of Tapentadol Immediate-Release (IR) Compared to Oxycodone Immediate-Release (IR)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Substance Abuse Detection |
Drug: Tapentadol IR Drug: Oxycodone IR |
| Study Type: | Observational |
| 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".
| Enrollment: | 646620 |
| Study Start Date: | February 2010 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Tapentadol IR |
Drug: Tapentadol IR
Opioid naive patients exposed to tapentadol IR from July 2009 to December 2010.
|
| Oxycodone IR |
Drug: Oxycodone IR
Opioid naive patients exposed to Oxycodone IR from July 2009 to December 2010.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | VICE PRESIDENT EPIDEMIOLOGY, Janssen R&D US |
| ClinicalTrials.gov Identifier: | NCT01545778 History of Changes |
| Other Study ID Numbers: | CR100822, RRA-5950 |
| Study First Received: | February 28, 2012 |
| Last Updated: | October 26, 2012 |
| Health Authority: | United States: None due to the nature of the study (Registry) |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
|
Substance abuse detection Opioids abuse Tapentadol immediate-release (IR) Oxycodone immediate-release (IR) |
Additional relevant MeSH terms:
|
Substance-Related Disorders Mental Disorders Oxycodone Narcotics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Analgesics, Opioid |
ClinicalTrials.gov processed this record on June 17, 2013