High-dose Fentanyl Matrix Application for Cancer Pain: Multicenter, Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 636
- 主要终点
- The percentage of patients who are very satisfied or satisfied with the pain treatment after the study drug administration
研究概览
简要总结
The purpose of this study is to show the clinical usefulness of fentanyl matrix by measuring satisfaction with pain treatment after administering fentanyl matrix in patients whose pain was not controlled sufficiently with the previous analgesic use in real practice at the investigator's discretion.
详细描述
This is a multi-center, open-label (all people know the identity of the intervention), prospective (the patients are identified and then followed forward in time for the outcome of the study) observational study. The study population comprises patients who are admitted to a study center during the study period and are receiving a strong oral long-acting opioid analgesic but deemed to control pain insufficiently. Since this study is an observational study conducted in real practice, a dose of fentanyl matrix should be adjusted depending on an individual patient's response at the investigator's discretion. However, for the patients whose pain is not sufficiently controlled despite administration of strong long-acting opioid analgesics, the minimum initial dose will be fentanyl matrix 75 micrograms/h and the investigator can adjust dosage according to the degree of the patients' pain control during the 9 days of the study period.
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 complaining of cancer pain which requires administration of long-acting opioid analgesics
- •Patients whose pain is not sufficiently controlled despite administration of strong long-acting opioid analgesics
- •Patients who are deemed to need an initial minimum dose of fentanyl matrix 75 micrograms/h
- •Patients who signed the informed consent form
排除标准
- •Patients with a history of or current drug or alcohol abuse
- •Childbearing women who are pregnant or likely to be pregnant during the study period and men who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception
- •Patients who are unable to use a transdermal system due to skin disease
- •Patients with history of hypersensitivity to opioid analgesics
- •Patients who are not eligible for the study participation based on warnings, precautions and contraindications in the package insert of the study drug at the investigator's discretion
研究组 & 干预措施
Fentanyl matrix
干预措施: No intervention (Drug)
结局指标
主要结局
The percentage of patients who are very satisfied or satisfied with the pain treatment after the study drug administration
时间窗: Day 10
The overall satisfaction is measured by a 5-point scale. Patients' answers are rated as: "very satisfied", "satisfied", "fair", "dissatisfied", or "very dissatisfied".
次要结局
- The change from baseline in Karnofsky Performance Status Scale(Baseline, Day 10)
- The change from baseline in pain intensity(Baseline, up to Day 10)
- Sleep disturbance caused by the number of awakening caused by pain the patient experienced over the last night(10 days)
- Sleep disturbance caused by pain the patient experienced over the last 24 hours(10 days)
- The change from baseline in Clinical Global Impression - Improvement (CGI-I)(Baseline, Day 10)
- Patient's Global Assessment(Day 10)
- Investigator's Global Assessment(Day 10)
- Dose of fentanyl matrix(9 days)