EUCTR2015-005110-30-IT进行中（未招募）1 期
A multicenter randomized trial to evaluate the efficacy of fentanyl pectin nasal spray (FPNS) versus Physician Choice (PC) - Usual Care (UC), in reducing incidental predictable breakthrough pain (IP-BTP) at swallowing in patients with head and neck cancer undergoing radiotherapy - FAST RELIEF
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 158
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male and female aged 18 years or over
- •2.Diagnosis of stage III-IV cancer of oral cavity, oropharynx, hypopharynx, larynx, salivary gland cancer.
- •3.Receiving radiation therapy (RT) with or without concurrent platinum based chemotherapy or cetuximab as first line treatment or as postoperative adjuvant treatment
- •4.Background pain managed with a stable fixed dose of opioid equivalent to 60mg oral morphine daily
- •5.Uncontrolled pain (IP-BTP) during swallowing with an intensity =4 on an 11-point numeric scale (0=no pain; 10=worst possible pain). This pain will have to be measured with the ingestion of a solid/liquid food (depending on the ability to swallow or less solid foods of the patient at moment)
- •6.Patients able to receive a nasal spray therapy
- •7.Willing and able to sign an informed consent form
- •8.Females with childbearing potential must provide a negative pregnancy test and both males and females must be using adequate contraception during the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 58
排除标准
- •1.Patients with known metastatic disease.
- •2.Known hypersensitivity to opioids, to Fentanyl or to drugs used in the PC-UC, and/or to study medications’ formulation ingredients.
- •3.Patients with impaired chemistry laboratory exams, assessed as routine clinical practice before radiotherapy start:
- •a.Hepatic function:
- •i.Total bilirubin > 2 times the upper-normal limit (ULN)
- •ii.ii. Serum transaminase > 5 times ULN
- •b.Renal function:
- •i.Serum creatinine concentration > 2 times ULN
- •4.Pregnant or breastfeeding women.
- •5.Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
- •6.Patients planned to receive other investigational treatments during study period
- •7.Patients with moderate to severe respiratory impairment
- •8.Patients assuming one of the following drug that can interfere with fentanyl:
- •Monoamine Oxidase Inhibitors, IMAO)
- •Ritonavir, ketoconazol, Itraconazolo, Troleandomicina, Claritromicina and Nelfinavir
- •Nasal decongestants
研究者
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