Fentanyl Matrix for the Treatment of Pain Caused by Osteoarthritis of the Knee or Hip: Improvement of Pain and Function: Multicenter, Open-label, Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 742
- 主要终点
- Change in pain intensity from baseline through final evaluation as measured by Numeric Rating Scale
研究概览
简要总结
The purpose of this study is to investigate the utility of fentanyl matrix for the treatment of pain due to osteoarthritis (OA) of knee or hip, which was not adequately controlled by non-opioid analgesic (e.g. NSAIDs or COX-II inhibitors) or weak opioids [tramadol HClacetaminophen, tramadol or codeine (or combinations with acetaminophen/ibuprofen)].
详细描述
This study is a prospective, open-label, non-interventional study. The objective of this study is to investigate the utility of fentanyl matrix after 8 week treatment of fentanyl matrix for the treatment of pain due to osteoarthritis (OA) of knee or hip, which was not adequately controlled by non-opioid analgesic (e.g. NSAIDs or COX-II selective inhibitors) or weak opioids [tramadol HCl with acetaminophen, tramadol or codeine (or combination with acetaminophen/ibuprofen)] in clinical practice according to the investigator's discretion. This study will investigate the usefulness of fentanyl matrix based on improvement in pain and function after Fentanyl matrix administration in patients who complained of pain caused by osteoarthritis and indicated for Fentanyl matrix administration in clinical practice at the investigator's discretion. This study will also measure the patients' functional improvement through Korean Version of WOMAC. Observational study - No investigational drug administered
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who complain of chronic pain caused by osteoarthritis of the knee or hip persisting for 3 months or longer
- •Patients who can fully observe the overall clinical study requirements including K-WOMAC completion at the investigator's discretion
- •Patients who complain of severe pain (NRS score = 7) because pain was not treated enough with the previous analgesic
- •Patients who have never been administered strong opioid analgesics over the last one month
排除标准
- •Patients with a history of the drug or alcohol abuse in the past or now
- •Childbearing women who are pregnant or likely to be pregnant during the study period and male subjects who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception (implant, injections, oral contraceptives, intrauterine device, etc.)
- •Patients who are unable to use a transdermal system due to skin disease
- •Patients with serious mental disorder
- •Patients with history of hypersensitivity to opioid analgesics
- •Patients with history of CO2 retention
- •Patients who are not eligible for the study participation based on warnings, precautions and contra medications in the package insert of the study drug at the investigator's discretion
研究组 & 干预措施
001
fentanyl matrix Knee osteoarthritis starting with 12mcg/h (flexible dose)
干预措施: fentanyl matrix (Drug)
002
fentanyl matrix Hip osteoarthritis starting with 12mcg/h (flexible dose)
干预措施: fentanyl matrix (Drug)
结局指标
主要结局
Change in pain intensity from baseline through final evaluation as measured by Numeric Rating Scale
时间窗: Baseline and week 8
次要结局
- Improved pain relief as measured using the K-WOMAC scale(baseline, week 4 and week 8)
- Improvement of sleep disturbance(baseline, week 4 and week 8)
- Impact of activity of daily activities measured by 5-point likert scale and social activities measured by 5-point likert scale(baseline, week 4 and week 8)
- Investigator and patient global assessment measured by 5-point likert scale(Week 4 and week 8)
- Improved pain relief as measured using the CGI-I(Week 4 and week 8)