NCT00485225已完成2 期
An Open-Label, Two-Stage, Phase II Study to Explore the Titration Schedule for Transitioning Opioid-Experienced Patients With Non-Malignant Moderate to Severe Chronic Pain From Current Opioid Therapy to EN3270.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Durect
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Safety and minimum titration period
研究概览
简要总结
Two stage study looking at different titration schedules in patients with moderate to severe non-malignant chronic pain. Up to 80 patients at approximately 15 centers in the US to be enrolled. Study participation is approximately 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Opioid experienced
- •Hx (min 3 months) of moderate to severe pain of non-malignant that is well controlled with current pain therapy
- •On a stable dose of opioid medication for greater than or equal to 14 days
- •Have an adequate personal support system including a co-habitant
- •Are able and willing to follow verbal and written instructions and provide written informed consent
排除标准
- •Are pregnant or lactating
- •Have pain secondary to a confirmed or suspected neoplasm
- •Have a history or physical examination finding incompatible with safe participation in the study
- •Have a history of alcohol or drug abuse
- •Have a history or physical examination finding of clinically significant skin abnormalities that would preclude use of a transdermal patch (e.g., psoriasis)
- •Have a history of or currently manifesting a clinically significant psychiatric disorder
- •Have a known history of allergy that negatively impacts respiratory function to a clinically significant level
- •Plan to have an MRI while on the study
- •Have any clinically significant condition that would, in the opinion of the investigator, preclude safe study participation
- •Are scheduled for surgery requiring general anesthesia within the study period
研究组 & 干预措施
Transdermal patch (EN3270) - Titration 1
Experimental
干预措施: EN3270 (Drug)
Transdermal patch (EN3270) - Titration 2
Experimental
干预措施: EN3270 (Drug)
Transdermal patch (EN3270) - Titration 3
Experimental
干预措施: EN3270 (Drug)
Transdermal patch (EN3270) - Titration 4
Experimental
干预措施: EN3270 (Drug)
结局指标
主要结局
Safety and minimum titration period
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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