Oxycodone User Registry (OUR)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective, Multi-center, Observational Registry of Patients Using Prescription Medications Containing Oxycodone Immediate Release for the Treatment of Pain|
- 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 [ Time Frame: Baseline, Day 1, Day 3, Day 7, Day 14, Day 21, Day 28 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||January 2010|
oxycodone immediate release (OXYRX) Characteristics of pts. receiving prescription medications containing OXYRX
Drug: oxycodone immediate release (OXYRX)
Characteristics of pts. receiving prescription medications containing OXYRX
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978328
|Study Director:||Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial||Ortho-McNeil Janssen Scientific Affairs, LLC|