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