Oxycodone User Registry (OUR)

Sponsor

Ortho-McNeil Janssen Scientific Affairs, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00978328

Collaborator

(none)

827

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: oxycodone immediate release (OXYRX)

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 Design

Study Type:

Observational

Actual Enrollment :

827 participants

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

Study Start Date :

Jun 1, 2009

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
001 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

Arm

Intervention/Treatment

001

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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