NCT00262678已完成3 期
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of EN3267 for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to determine the effectiveness and safety of sublingual fentanyl tablets in relieving breakthrough pain in cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 17 years of age or older
- •Stable cancer-related pain.
- •Are receiving a stable, fixed-schedule oral opioid regimen equivalent to 60 to 1000 mg of oral morphine per day or transdermal fentanyl therapy equivalent to 50 to 300 µg/h, and are on a stable dose of opioid medication for relief of breakthrough pain for at least 14 days prior to screening.
- •Experiencing 1-4 episodes of breakthrough pain per day.
- •Meet the criteria defined in the Eastern Cooperative Oncology Group (ECOG) Performance Status for Grade 0, 1, or 2.
排除标准
- •Are pregnant or lactating.
- •Have uncontrolled or rapidly escalating pain.
- •Have moderate to severe ulcerative mucositis.
- •Have a cardiopulmonary disease that would increase the risk of administering potent opioids.
- •Have neurologic or psychologic disease that would compromise data collection
- •Have any clinically significant condition that would, in the investigator's opinion, preclude study participation.
- •Are currently taking monoamine oxidase inhibitors (MAOIs), or have taken MAOIs within 14 days prior to enrolling in the study.
- •Have received strontium 89 therapy within 60 days prior to entering the study.
- •Have received anti-neoplastic therapy within 2 weeks of study entry that, in the investigator's opinion, will influence assessment of breakthrough pain
- •Have received any investigational drug (non-approved) within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than EN3267 during the course of the study.
- •Have hypersensitivities, allergies, or contraindications to fentanyl.
- •Have a significant prior history of substance abuse or alcohol abuse.
- •May have difficulty complying with the protocol, as assessed by the investigator.
研究者
研究点 (2)
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