Phase 3 Study Evaluating Fentanyl Transmucosal in the Prevention of Pain Induced by Mobilization During Radiotherapy in Patients With Bone Metastasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Drug efficacy
研究概览
简要总结
The clinical trial is a stage 3 study to determine the role of fentanyl transmucosal in the prevention of pain induced by mobilization in patients receiving a bone metastasis radiation for bone metastasis irradiations
详细描述
Participation to the trial will be proposed to the patient by the investigator in charge of the analgesic irradiation during the preliminary scanner session that will be held before radiotherapy session(s). Patients with a VAS≤ 3 will be excluded.
PecFent and Placebo will be delivered by Archimedes Pharma When starting the radiotherapy session(s) (2 days after the preliminary scanner session), the medic will collect the patient signed informed consent, will deliver the treatment 1 dose of fentanyl transmucosal (Pecfent® ) 100µg in naive patients or 1 dose of Pecfent® 200µg in patient with a stable opioid background pain treatment or placebo) and will collect pain intensity value with a patient VAS collected before and at the end of the radiotherapy session. Finally patient & radiotherapists global satisfaction will be collected An assessment a week the end of the radiotherapy session will be assessed by investigator consisting in a Patient global satisfaction
Study follow up:
Patients will receive a phone call a week after the radiotherapy session to collect patient global satisfaction score related with the global management of the radiotherapy session
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Male or female
- •More than 18 years old
- •Proven histological cancer with bone metastasis
- •SignedInform consent form
- •Patient with pain assed as VAS Superior to 3 when positioning the patient in the preliminary scanner session
排除标准
- •VAS>3 before radiotherapy treatment (establishment of an appropriate analgesic treatment) (session
- •Any SAO treatment on going
- •Pregnant or lactating woman
- •Hypersensitivity or safety issues to any opioïd treatment
- •Poor nasal mucosa (defined on clinical doctor assessment)
- •Severe obstructive lung conditions or respiratory depression
- •Renal insufficiency with creatinine clearance inferior to 45 ml/min
- •Hepatic insufficiency
- •Patient misunderstanding of the content and objective of the trial
- •Patient under supervision or guardianship
- •SAO intake 4 hours before the radiotherapy session
- •Patient participating to any other pain management trial
- •Morphine pump usage
研究组 & 干预措施
Pecfent
Patients will receive 100 µg of transmucosal Pecfent before radiotherapy session (or 200 µg in patients with a stable opioid background pain treatment)
干预措施: fentanyl transmucosal (Drug)
Placebo
Patients will receive 100 µg of transmucosal placebo before radiotherapy session or 200 µg in patients with a stable opioid background pain treatment)
干预措施: Placebo (Drug)
结局指标
主要结局
Drug efficacy
时间窗: 30 minutes
Pain Intensity Difference (PID) with the VAS considering the higher Pain Intensity (PI) score notified by the patient during the scanner and radiotherapy session
次要结局
- Patient global satisfaction(one week)
- Adverse event of Pecfent(one week)
- Rescue medication(30 minutes)
- Radiotherapy session duration(one hour)