Fentanyl Buccal Soluble Films Feasible Dose Range Study for Breakthrough Pain in Taiwanese Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Optimal dose calculation of Painkyl®
研究概览
简要总结
Primary Objective:
To determine the feasible dose range of Painkyl® required for Taiwanese population.
Secondary Objectives:
To evaluate the efficacy of Painkyl® by calculating squared mean of pain intensity difference at 30 minutes after taking Painkyl® (SPID30, an 11-point scale).
To evaluate subjects' satisfaction by conducting global evaluation of medication performance (a 5-point categorical scale).
To identify percentage of episodes requiring rescue medication during maintenance treatment period.
To evaluate the safety data of Painkyl® for breakthrough pain.
详细描述
The primary endpoint was the feasible range of FBSF required for Taiwanese population. The secondary endpoints were the difference in pain intensity at 30 minutes (PID30) after FBSF administration, subjects' satisfaction, and the percentage of episodes requiring rescue medications.
Pain intensity was determined using an 11-point numeric scale from 0="no pain" to 10="worst pain." Patients were assessed with baseline pain as well as pain intensity at 30 minutes after dosing. The PID30 was obtained by baseline pain score minus score rated 30 minutes after dosing.
Patient's satisfaction was assessed using a 5-point (poor, fair, good, very good, and excellent) categorical scale at 30 minutes after taking FBSF with the following question: "What was your overall satisfaction with the medication?" At each episode of BTP, subjects recorded whether a rescue medication was taken after administration of FBSF.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a. a stable current regimen of oral opioids equivalent to 60-1000 mg/day of oral morphine or 20-120 mg/day of iv morphine or 25-300 mcg/hr of transdermal fentanyl for one week or longer;
- •b. regularly experienced 1 to 3 breakthrough pain episodes per day that required additional opioids from pain control;
- •c. at least partial relief of breakthrough pain by use of opioid therapy;
- •d. 20 years of age or older;
- •e. ability to understand and willingness to sign a written informed consent document;
- •f. able to self-administer the study medication correctly or has the availability of a responsible adult caregiver available to administer the study medication correctly;
- •g. willing and able to complete patient diary with each pain episode
排除标准
- •a. rapidly escalating pain (e.g., regularly more than 3 breakthrough pain episodes per day) that are hard to be controlled by analgesics;
- •b. history of hypersensitivity or intolerance to fentanyl;
- •c. cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression;
- •d. psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary;
- •e. moderate (Grade 3) to severe (Grade 4) mucositis (subjects with less than moderate mucositis are permitted and must be instructed to not apply the Painkyl® film at a site of inflammation);
- •f. abnormal oral mucosa which will impede drug absorption;
- •g. currently under other treatments that may alter effect of pain control based on investigator's judgment;
- •h. recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse;
- •i. use of an investigational drug within 4 weeks preceding this study;
- •j. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential;
研究组 & 干预措施
Fentanyl buccal soluble film (FBSF)
Single arm
干预措施: Fentanyl buccal soluble film (FBSF) (Drug)
结局指标
主要结局
Optimal dose calculation of Painkyl®
时间窗: Within 2 weeks
Time to "optimal" dose of an open-label study medication in the titration phase. During the dose titration period, subjects were administered with FBSF (Painkyl®) in a dose escalation manner until a treatment dose was identified (defined as an adequate relief of BTP observed for at least two consecutive episodes). All patient started with a dose of 200 μg and increased by 200 μg in each subsequent episode until an adequate pain relief with tolerable side effects was achieved.
次要结局
- Efficacy Phase : Pain intensity difference at 30 minutes (PID30) after treatment(During the efficacy phase, at each episode of breakthrough pain, 30 minutes after taking dose of study drug, at 0 and 10 minutes after taking dose of study drug)
- The percentage of episodes requiring rescue medications.(Within 2 weeks)
- Efficacy Phase : Subjects' satisfaction score at 30 minutes after treatment(During the efficacy phase, at each episode of breakthrough pain, 30 minutes after taking dose of study drug)
- Incidence of adverse events (AEs), serious adverse events (SAEs) [Safety and Tolerability](From the date of study entry until 30 days after the last dose of study treatment)