Conversion From Fast Acting Oral Opioids to Abstral® (SL Fentanyl) in Opioid Tolerant Cancer Patients With Breakthrough Pain
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Orexo AB
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Response rate in patients converted to SL fentanyl.
研究概览
简要总结
The purpose of this study is to evaluate safety and efficacy when using a novel dose conversion strategy to switch from immediate release oral opioids to sublingual (SL) fentanyl (Abstral) for treatment of breakthrough cancer pain (BTcP).
详细描述
The study aims to show that in the advanced stage of cancer the individual patient already on high doses of BTcP medication will benefit from starting treatment on a higher first dose of SL fentanyl thus reducing the number of dosing steps with insufficient pain relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent obtained.
- •18 years or older, of both genders.
- •Opioid tolerant patients
- •Estimated frequency of BTcP 0.5-4 times a day.
排除标准
- •Treatment with SL fentanyl within two weeks prior to screening.
- •Recent or planned therapy that would alter pain or responses to analgesics.
- •Treatment with monoamine oxidase inhibitor < 14 days before or concurrent with SL fentanyl treatment.
- •Significantly reduced liver and/or kidney function.
- •Significant prior history of substance abuse.
- •Pregnancy, breast feeding or woman of childbearing potential not using adequate birth control.
研究组 & 干预措施
SL Fentanyl conversion
- Baseline period: 7-15 episodes of breakthrough cancer pain treated with prior IR opioid medication
- Treatment period: Conversion to SL Fentanyl at a Fentanyl:Prior opioid conversion factor of 1:50 (using the estimated Morphine Sulphate Equivalent dose for the prior opioid). SL Fentanyl use was followed for 8-15 episodes of breakthrough cancer pain. SL Fentanyl dose could be titrated between episodes.
干预措施: SL fentanyl (Drug)
结局指标
主要结局
Response rate in patients converted to SL fentanyl.
时间窗: 30 minutes post dose
A subject is defined as responder if the change of Pain Intensity (PI) on the Numerical Rating Scale (NRS) rated from 0 to 10, at 30 minutes (PID30) is similar or higher after the conversion to SL fentanyl compared to baseline PID30 as assessed by standard care rescue treatment of BTcP episodes.
次要结局
- Occurrence of AEs, withdrawals(during a maximum treatment period of 21 days.)
- Responder rate in patients converted to SL fentanyl as assessed by the PID15.(15 minutes post dose)
- Patients preference of treatment (baseline treatment/SL fentanyl).(end of study)
- Edmonton Symptom Assessment System (ESAS) Symptom Distress Score (SDS)(24 hour assessment on days with pain episodes)
- Patient's global assessment of treatment (patient satisfaction).(2 occasions)