Impact of Fentanyl Matrix on Improvement of Pain and Functioning in Spinal Disorder-related Pain: Multicenter, Open Label, Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,576
- 主要终点
- Pain intensity with Numeric Rating Scale
研究概览
简要总结
The purpose of this observational study is to investigate the impact of fentanyl matrix on improvement of pain and functioning in spinal disorder-related chronic pain.
详细描述
This study is a prospective, open-label, non-interventional study. The objective of the study is to investigate the impact of fentanyl matrix on improvement of pain and functioning after 8-week treatment of fentanyl matrix in the patients who complained of spinal disorder-related chronic pain in clinical practice according to the investigator's discretion. The primary endpoint is a percent of pain intensity difference between baseline and week 8 of the study. Each patients will evaluate their pain intensity every 28 days during the 8 weeks. The secondary objectives are to observe the change in the following variables after administrating fentanyl matrix; K-ODI (Korean version - Oswestry Disability Index) score, sleep disturbance, disturbance of activities of daily living and disturbance of social activities. In addition, Investigator and patient global assessment, patient preference, CGI-I (Clinical Global Impression - Improvement) and Adverse Events will be investigated. LDK: Lumbar degenerative kyphosis, CRPS: Complex Regional Pain SYndrome, FBSS: Failed Back Surgery Syndrome 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 spinal disorder-related chronic pain persisting for 3 months or longer
- •Patients who can fully observe the overall clinical study requirements including K-ODI 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 fentanyl matrix 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 patients 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
干预措施: fentanyl (Drug)
002
干预措施: fentanyl (Drug)
003
干预措施: fentanyl (Drug)
004
干预措施: fentanyl (Drug)
005
干预措施: fentanyl (Drug)
006
干预措施: fentanyl (Drug)
007
干预措施: fentanyl (Drug)
结局指标
主要结局
Pain intensity with Numeric Rating Scale
时间窗: baseline, week 4 and week 8
次要结局
- K-ODI (Korean version of Oswestry Disability Index)(baseline, week 4 and week 8)
- Improvement of sleep disturbance(baseline, week 4 and week 8)
- Impact of activity of daily living and social activities(baseline, week 4 and week 8)
- Investigator and patient global assessment(baseline, week 4 and week 8)
- CGI-I (Clinical Global Impression)(baseline, week 4 and week 8)