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

NCT ID: NCT01545778

Last Updated: 2012-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

646620 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Substance Abuse Detection

Keywords

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Substance abuse detection Opioids abuse Tapentadol immediate-release (IR) Oxycodone immediate-release (IR)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Tapentadol IR

Tapentadol IR

Intervention Type DRUG

Opioid naive patients exposed to tapentadol IR from July 2009 to December 2010.

Oxycodone IR

Oxycodone IR

Intervention Type DRUG

Opioid naive patients exposed to Oxycodone IR from July 2009 to December 2010.

Interventions

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Tapentadol IR

Opioid naive patients exposed to tapentadol IR from July 2009 to December 2010.

Intervention Type DRUG

Oxycodone IR

Opioid naive patients exposed to Oxycodone IR from July 2009 to December 2010.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Janssen R&D US

Principal Investigators

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

References

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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.

Reference Type DERIVED
PMID: 23253635 (View on PubMed)

Other Identifiers

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RRA-5950

Identifier Type: OTHER

Identifier Source: secondary_id

CR100822

Identifier Type: -

Identifier Source: org_study_id