Efficacy and Safety Study of Fentanyl Transdermal (Fentanest®)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 5
- 主要终点
- Primary: formulation tolerability (assessed by adverse events incidence). Co primary: formulation analgesic efficacy (assessed by rescue medication demand).
研究概览
简要总结
Eligible patients who agree to participate will migrate from oral opioids to transdermal patches and be followed for four weeks. Oral morphine will be provided as pain rescue medication. The patients will inform the adverse events and rescue medication consumption. The number of Fentanest® patches will be adjusted every visit aiming to reduce the rescue medication consumption and adverse events to a minimum. The WHO-QOL- bref (quality of life questionary) will be filled before and after the use of Fentanest®. Patients showing benefit are eligible to a 3 weeks compassionate study.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients aged from 18 to 70 years with cancer chronic pain who received in the last 4 weeks at least 40 mg of oral morphine or equianalgesic dose of other opioids. If using adjuvant analgesics, these must be in stable doses in the last 4 weeks.
排除标准
- •Life expectancy bellow 4 months;
- •Karnofsky score < 60;
- •Hypersensitivity to opioids or patches;
- •Acute pain;
- •Non cancer pain;
- •Increased intracranial pressure;
- •Conditions that prevent the patient to understand the study directions and/or give his consent;
- •Neuromuscular disorders with increased risk of respiratory depression;
- •Impossibility to receive rescue oral morphine; active infections;
- •Pregnancy and nursing;
- •Uncontrolled diabetes mellitus or arterial hypertension;
- •Need of anticoagulation;
- •Need to operate machines or vehicles;
- •Important skin disorders;
- •History of severe allergic reactions;
- •BMI ≥ 35;
- •Safety exams outrange;
- •Participation in another clinical trial within the last 2 months;
- •Investigator´s opinion.
研究组 & 干预措施
Fentanyl Transdermal
干预措施: Fentanyl Transdermal (Drug)
结局指标
主要结局
Primary: formulation tolerability (assessed by adverse events incidence). Co primary: formulation analgesic efficacy (assessed by rescue medication demand).
时间窗: 4 weeks folow-up
次要结局
- Establish the correspondence between the dose of oral opioids available in Brazil and number of patches required. Establish directions for secure and effective migration from oral opioids to this formulation. Quality of life improvement (WHO-QOL-bref).(3 months)