Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Primary endpoint of this study is to prove the non-inferiority in fentanyl plasma concentrations 12 hours after dose augmentation compared to 48 hours after dose augmentation within each patient using a bioequivalence approach
研究概览
简要总结
The primary objective is to evaluate the effect of loading boluses when dose incresaing treatment with SC fentanyl in patients with cancer. The primary endpoint of this study is to prove the non-inferiority of fentanyl plasma concentrations 12 hours after dose augmentation compared to 48 hours after dose augmentation within each patient.
Patients will be treated with additional loading boluses and plasma-PK samples will be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Able to understand the written information and able to give informed consent.
- •Current or planned treatment with SC fentanyl for cancer-related pain
排除标准
- •Pregnancy or/ and breastfeeding
- •Other ways of using fentanyl (sublingual, nasal spray and oromucosal)
- •Liver function CPS B or C
- •The use of strong CYP3A4 inhibitors of inducers [9]
- •Presence of somnolence, respiratory depression or CTCAE grade 2 adverse events.
研究组 & 干预措施
Intervention arm
Patients are given loading doses when dose-increasing fentanyl. The concentrations at 12 and 48 hours after dose increase will be compared
干预措施: Fentanyl (Drug)
结局指标
主要结局
Primary endpoint of this study is to prove the non-inferiority in fentanyl plasma concentrations 12 hours after dose augmentation compared to 48 hours after dose augmentation within each patient using a bioequivalence approach
时间窗: 48 hours after dose increase
Using a paired t-test the geometric mean of the ratio of the two fentanyl plasma concentrations will be compared. The 90% confidence interval of the geomteric mean should fall within the range of 80 - 125%.
次要结局
- Investigate the safety of the loading bolus strategy by assessing whether CTCAE grade III or higher occur as a consequence of the fentanyl loading boluses.(up to 48 hours after dose increase)
- Describe the course of patient reported pain intensity in the 48 hours following the loading boluses.(up to 48 hours after dose increase)
- Accurately assess the rate of fentanyl absorption after SC fentanyl administered as a bolus.(up to 48 hours after dose increase)
研究者
Prof. R.H.J. Mathijssen, MD, PhD
prof.R.H.J. Mathijssen
Erasmus Medical Center