NCT00263575已完成3 期
A Multiple-Dose, Non-Randomized, Open-Label, Multicenter Study to Evaluate the Long-Term Safety and Effectiveness of EN3267 in the Treatment of Breakthrough Pain in Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Evaluate the Long-term Safety and Effectiveness of EN3267
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and effectiveness of EN3267 in treating breakthrough pain episodes in opioid cancer patients who are using stable doses of opioid medication.
详细描述
This was a Phase 3 non-randomized, open-label, multicentre study designed to evaluate the long-term safety of EN3267 in the treatment of BTcP in opioid-tolerant cancer patients. The study was conducted in 2 parts:
- A Titration Period during which patients had up to 2 weeks to determine a single, effective dose of study medication (EN3267) for adequate treatment of BTcP, and
- A maintenance Period of up to 12 months in which episodes of BTcP were treated with study medication.
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
- 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.
- •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
- •Have previously been exposed to EN
- •Are pregnant or lactating.
- •Have uncontrolled or rapidly escalating pain.
- •Have any clinically significant condition that would, in the investigator's opinion, preclude participation in the study or compromise data collection. These conditions may include cardiopulmonary disease, and/or neurologic/psychologic conditions.
- •Are scheduled to take MAOIs (monoamine oxidase inhibitors) during the study.
- •Are scheduled to receive anti-neoplastic therapy that, in the investigator's opinion, will influence assessment of breakthrough pain.
- •Are scheduled to receive an investigational drug other than EN3267 during the course of the study.
- •Have hypersensitivity, allergy or contraindication to fentanyl.
- •Have significant prior history of substance abuse or alcohol abuse.
- •Would have difficulty complying with the protocol, as assessed by the investigator.
- •Are unable to read, write, or comprehend the English language in order to complete diaries.
研究组 & 干预措施
sublingual fentanyl tablet
Experimental
干预措施: EN3267 (Drug)
结局指标
主要结局
Evaluate the Long-term Safety and Effectiveness of EN3267
时间窗: screening, 2 week titration period and 12 monthly study visits
次要结局
未报告次要终点
研究者
研究点 (1)
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