Oxycodone User Registry (OUR)

Condition(s) targeted: Pain

Intervention: oxycodone immediate release (OXYRX) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Ortho-McNeil Janssen Scientific Affairs, LLC

Official(s) and/or principal investigator(s):
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study Director, Affiliation: Ortho-McNeil Janssen Scientific Affairs, LLC

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

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.

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

Study design: Cohort, Prospective

Primary outcome: 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

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.

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

Birmingham, Alabama, United States; Recruiting

Homewood, Alabama, United States; Recruiting

Phoenix, Arizona, United States; Recruiting

Scottsdale, Arizona, United States; Recruiting

Tucson, Arizona, United States; Recruiting

Carmichael, California, United States; Recruiting

San Diego, California, United States; Recruiting

Los Gatos, California, United States; Recruiting

La Mesa, California, United States; Recruiting

Fresno, California, United States; Recruiting

Buena Park, California, United States; Recruiting

Anaheim, California, United States; Recruiting

Aurora, Colorado, United States; Recruiting

Hartford, Connecticut, United States; Recruiting

Jacksonville, Florida, United States; Recruiting

Bradenton, Florida, United States; Recruiting

Venice, Florida, United States; Recruiting

Sunrise, Florida, United States; Recruiting

Merritt Island, Florida, United States; Recruiting

Vero Beach, Florida, United States; Recruiting

Plantation, Florida, United States; Recruiting

Tampa, Florida, United States; Recruiting

North Miami, Florida, United States; Recruiting

St Petersburg, Florida, United States; Recruiting

Miami, Florida, United States; Recruiting

Deland, Florida, United States; Recruiting

Decatur, Georgia, United States; Recruiting

Canton, Georgia, United States; Recruiting

Chicago, Illinois, United States; Not yet recruiting

Shreveport, Louisiana, United States; Recruiting

Baltimore, Maryland, United States; Recruiting

Boston, Massachusetts, United States; Not yet recruiting

Fall River, Massachusetts, United States; Recruiting

Cherry Hill, New Jersey, United States; Recruiting

Dover, New Jersey, United States; Recruiting

Bridgeport, New Jersey, United States; Recruiting

Mamaroneck, New York, United States; Recruiting

New York, New York, United States; Not yet recruiting

Bay Shore, New York, United States; Recruiting

Charlotte, North Carolina, United States; Recruiting

Monroe, North Carolina, United States; Recruiting

Asheboro, North Carolina, United States; Recruiting

Winston Salem, North Carolina, United States; Recruiting

Duncansville, Pennsylvania, United States; Recruiting

Pittsburgh, Pennsylvania, United States; Recruiting

Columbia, South Carolina, United States; Recruiting

Myrtle Beach, South Carolina, United States; Not yet recruiting

North Charleston, South Carolina, United States; Recruiting

Memphis, Tennessee, United States; Recruiting

Mc Minnville, Tennessee, United States; Recruiting

Spring, Texas, United States; Recruiting

Sugar Land, Texas, United States; Recruiting

Danville, Virginia, United States; Recruiting

Oak Creek, Wisconsin, United States; Recruiting

To learn how to participate in this trial please click here.

Starting date: June 2009
Ending date: January 2010
Last updated: September 25, 2009