跳至主要内容
临床试验/NCT00978328
NCT00978328已完成不适用

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

Ortho-McNeil Janssen Scientific Affairs, LLC0 个研究点目标入组 827 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
827
主要终点
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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

001

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

干预措施: oxycodone immediate release (OXYRX) (Drug)

结局指标

主要结局

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

时间窗: Baseline, Day 1, Day 3, Day 7, Day 14, Day 21, Day 28

次要结局

未报告次要终点

研究者

申办方类型
Industry

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