The Clinical Use and Safety of TTS (Fentanyl) in the Management of Pain in Patients With Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 主要终点
- Assessment of pain relief; Rescue medication usage
研究概览
简要总结
The purpose of this study is to establish the clinical utility and safety of fentanyl TTS (a transdermal patch delivering the narcotic pain reliever fentanyl) in the treatment of pain in patients with cancer.
详细描述
This is a single-arm, non-randomized, open-label, multi-center trial to assess the safety and clinical utility of the fentanyl Transdermal Therapeutic System (TTS) for the treatment of pain in patients with cancer. Patients requiring narcotics for pain management are converted from conventional analgesics to oral morphine, and titrated to a stable dose prior to the initiation of fentanyl TTS. The stabilized morphine dose provides the basis for the calculation of the equi-analgesic dose of fentanyl TTS based on established analgesic potency ratios. Patients replace the fentanyl TTS patch every 3 days. Immediate-release morphine is available as rescue medication for breakthrough pain. The adequacy of analgesia, use of morphine rescue medication, and routine safety evaluations are obtained at scheduled intervals throughout the trial.
fentanyl patch
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients currently taking narcotic analgesics for relief of cancer pain
- •Able to communicate effectively
- •Living with a constant caretaker
- •Who have achieved a stabilized morphine dose that provides adequate pain control
排除标准
- •Patients with a life expectancy of less than 30 days
- •Having history of carbon dioxide (CO2) retention or other cardiac, respiratory or nervous system disease (precludes participation because of the potential for respiratory depression)
- •Has severe renal or hepatic insufficiency, active skin disease, a history of allergic reactions to narcotics, or a history of narcotic abuse prior to treatment with narcotics for cancer-related pain
- •Has a mental or psychiatric disease
- •If female of child-bearing potential, currently pregnant or not practicing an acceptable method contraception
结局指标
主要结局
Assessment of pain relief; Rescue medication usage
次要结局
- Incidence and severity of adverse events