Oxycodone User Registry (OUR)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

827 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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001

oxycodone immediate release (OXYRX) Characteristics of pts. receiving prescription medications containing OXYRX

oxycodone immediate release (OXYRX)

Intervention Type DRUG

Characteristics of pts. receiving prescription medications containing OXYRX

Interventions

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oxycodone immediate release (OXYRX)

Characteristics of pts. receiving prescription medications containing OXYRX

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No