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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01545778
First received: February 28, 2012
Last updated: October 26, 2012
Last verified: October 2012

February 28, 2012
October 26, 2012
February 2010
February 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01545778 on ClinicalTrials.gov Archive Site
  • 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".
Same as current
Not Provided
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Risk of Shopping Behavior of Tapentadol Immediate-Release (IR) Compared to Oxycodone Immediate-Release (IR)
Risk of Shopping Behavior of Tapentadol IR Immediate-Release (IR) Compared to Oxycodone IR 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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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.

Substance Abuse Detection
  • 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.
  • Tapentadol IR
    Intervention: Drug: Tapentadol IR
  • Oxycodone IR
    Intervention: Drug: Oxycodone IR
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
646620
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01545778
CR100822, RRA-5950
Not Provided
VICE PRESIDENT EPIDEMIOLOGY, Janssen R&D US
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP