Oxycodone User Registry (OUR)

Pain Clinical Trial

Official title:

A Prospective, Multi-center, Observational Registry of Patients Using Prescription Medications Containing Oxycodone Immediate Release for the Treatment of Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978328
• Other study ID #: CR015670
• Status: Completed
• Phase: N/A
• First received: September 15, 2009
• Last updated: April 1, 2010
• Start date: June 2009
• Est. completion date: January 2010

Study information

• Verified date: April 2010
• Source: Ortho-McNeil Janssen Scientific Affairs, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to describe clinical and demographic characteristics of patients receiving prescription medications containing oxycodone immediate release (OXYRX), to characterize patient and prescriber perceptions of the effectiveness outcomes and tolerability of OXYRX treatment, to describe prescriber decision-making about pain management with a Schedule II opioid and to explore how prescribers identify suspected abuse of pain medications.

Description:

Real-world utility of Schedule II immediate release opioids depends on both efficacy and side effects. Few existing data sources systematically captured opioid-related side effects and their impact on patient outcomes and physician practice. This study is expected to lead to an in-depth understanding of patient and prescriber perceptions of both effectiveness and side effects associated with medications containing the most widely prescribed oral Schedule II immediate release opioid for pain management, oxycodone immediate release (OXYRX), alone (eg, Roxicodone®) or in combination (eg, Percocet®, Tylox®) in actual clinical practice. This is a prospective, multi-center, observational patient registry. Adult outpatients who have pain due to a non-cancerous condition meeting study eligibility will be enrolled. Prescribers will treat patients according to their usual practice. Prescribers will treat patients, meeting study eligibility, with OXYRX according to their usual practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 827
• Est. completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Pain requiring treatment with a Schedule II immediate release opioid within 3 days following the baseline visit

• and pain that warrants treatment with a prescription for OXYRX PRN (alone or in combination) for at least 5 days after the baseline visit

Exclusion Criteria:

• Use of any Schedule II opioid within 30 days prior to informed consent

• planned use of other opioids (Schedule II-V) while using OXYRX

• malignancy other than superficial skin cancers (ie, basal cell, squamous cell) within the past year

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• oxycodone immediate release (OXYRX)
Characteristics of pts. receiving prescription medications containing OXYRX

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ortho-McNeil Janssen Scientific Affairs, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe clinical / demographic characteristics of patients receiving OXYRX; characterize patient / prescriber perceptions of the effectiveness outcomes and tolerability of OXYRX treatment; describe prescriber decision-making about pain meds		Baseline, Day 1, Day 3, Day 7, Day 14, Day 21, Day 28	No