JPRN-jRCT2080221194未知3 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled PhaseIII Study to Evaluate the Efficacy and Safety of OVF in Opioid tolerant Patients With Cancer and Breakthrough Pain.
试验速览
- 阶段
- 3 期
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Patients who submitted informed consent
- •2)Patients aged 20 years or older at the time of acquisition of informed consent
- •3)Patients with cancer-related pain associated with histologically or cytologically confirmed malignant solid or hematological malignancies
- •4)Patients notified of their cancer
- •5)Patients with Eastern Cooperative Oncology Group(ECOG) performance status(P.S.) 0-2 or patients with ECOG P.S. 3 due to disturbance of motility (bone fracture, paralysis, etc.)
- •6)Patients who are expected to be alive at least 3 months.
- •7)Patients with well-controlled persistent pain who are tolerant to an around-the-clock (ATC) dose of oral morphine 30-1000 mg/day, or equivalent potent opioid administered for a period of 7 days or more before observation registration
- •8)Patients who are expected to have breakthrough pain controlled by standard rescue medications (Oral, intrarectal or intravenous/subcutaneous morphine preparation, intravenous fentanyl preparation or oral oxycodone preparation)at least once and not more than 4 times daily
排除标准
- •1)Patients hypersensitive to fentanyl or other opioids
- •2)Patients receiving subarachnoidal opioids
- •3)Patients with grade 2-4 findings of stomatitis or dry mouth (clinical examination or functional/symptomatic) . For the stomatitis (clinical examination ), it is limited to that on either side of the buccal cavity.
研究者
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