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OpenTrials
Completed

NCT Number: NCT00978328

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oxycodone immediate release (OXYRX)

Drug

Characteristics of pts. receiving prescription medications containing OXYRX

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ortho-McNeil Janssen Scientific Affairs, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Study completion
2010
First posted
Sep 16, 2009
Registry last updated
Apr 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.