Oxycodone User Registry (OUR)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00978328

Enrollment

827

Registered

2009-09-16

Start date

2009-06-30

Completion date

2010-01-31

Last updated

2010-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Pain conditions, Oxycodone immediate release, Percocet®, Tylox®, Roxicodone®, Registry, Side effects, Observational, Pain management

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.

Interventions

DRUGoxycodone immediate release (OXYRX)

Characteristics of pts. receiving prescription medications containing OXYRX

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026