Oxycodone User Registry (OUR)

Completed

• Conditions: Pain
• Interventions: Drug: oxycodone immediate release (OXYRX)

• Registration Number: NCT00978328
• Lead Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-09-15
• Study First Submitted QC: 2009-09-15
• Study First Posted: 2009-09-16
• Study Completion: 2010-01
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-01
• Last Update Posted: 2010-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 827

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
001	oxycodone immediate release (OXYRX)	oxycodone immediate release (OXYRX) Characteristics of pts. receiving prescription medications containing OXYRX

Primary Outcome Measures

Name	Time	Method
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