The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement: Multicenter, Prospective, Open-label, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 410
- 主要终点
- The percentage of patients with mean % Pain Intensity Difference (%PID) >= 50% from baseline to endpoint
研究概览
简要总结
The purpose of this study is to assess the effectiveness and tolerability of Fentanyl matrix in chronic non-cancer pain.
详细描述
This is a multicenter, prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study), open-label (all people know the identity of the intervention), observational study intended to examine the effectiveness of Fentanyl matrix through the degree of improvement of pain. Fentanyl matrix is a transdermal (through the skin) system providing continuous delivery of fentanyl for 72 hours. Fentanyl matrix will be administered to patients with chronic (prolonged) non-cancer pain under routine practice during 12 weeks. Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.
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
- •Complain of chronic non-cancer pain that persists for >= 3 months
- •Pain inadequately controlled by previous treatment with narcotic analgesics (opium or opium-like compounds with potent analgesic effects, eg, tramadol, codeine, morphine, oxycodone)
- •Women must be postmenopausal, surgically sterile, abstinent, or practicing an effective method of birth control if they have childbearing potential
- •Male patients who agree to use a method of birth control and not to donate sperm for 1 month after the last dose of the study drug
- •A written informed consent for study participation
排除标准
- •Experience of treatment with Fentanyl matrix within the past 4 weeks
- •No previous experience of use of narcotic analgesics
- •Past or current history of alcohol or drug abuse
- •Cannot use transdermal analgesics due to skin disorder
- •Have serious psychiatric disorder and cannot complete overall study procedures and questionnaire in the judgment of the investigator
研究组 & 干预措施
Fentanyl matrix
干预措施: Fentanyl matrix (Drug)
结局指标
主要结局
The percentage of patients with mean % Pain Intensity Difference (%PID) >= 50% from baseline to endpoint
时间窗: 12 weeks
Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
次要结局
- The degree of Interference with Daily Life Performance due to Pain(12 weeks)
- The difference between the patient's pain treatment goal set at baseline(Baseline, Week 12)
- The degree of night sleep disturbance due to pain(12 weeks)
- The degree of Interference with Social Life Performance due to Pain(12 weeks)
- The patient's global assessment of pain treatment(12 weeks)
- The investigator's global assessment of pain treatment(12 weeks)
- The change from baseline in mean pain intensity(Baseline, Week 12)