NCT01545778

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
646,620

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
Last Updated

October 29, 2012

Status Verified

October 1, 2012

Enrollment Period

2 years

First QC Date

February 28, 2012

Last Update Submit

October 26, 2012

Conditions

Substance Abuse Detection

Keywords

Substance abuse detectionOpioids abuseTapentadol immediate-release (IR)Oxycodone immediate-release (IR)

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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

    12 months

Study Arms (2)

Tapentadol IR

Drug: Tapentadol IR

Oxycodone IR

Drug: Oxycodone IR

Interventions

Tapentadol IRDRUG

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

Tapentadol IR
Oxycodone IRDRUG

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

Oxycodone IR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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 \[The index date is the date of the first prescription for tapentadol IR or oxycodone IR after June 30, 2009\]

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 23253635DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

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

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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 28, 2012

First Posted

March 7, 2012

Study Start

February 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

October 29, 2012

Record last verified: 2012-10