A Phase 2, Open-label Pilot Study of TRV130 for the Treatment of Moderate to Severe Acute Pain Associated With Long Bone Fracture
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Trevena Inc.
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Proportion of Patients Achieving Clinical Response, Defined as Achieving a NPRS <= 3, Without Requiring Rescue Pain Medication.
研究概览
简要总结
The primary objective is to evaluate the analgesic efficacy of TRV130 for moderate to severe acute pain in patients presenting to the emergency department (ED) with a suspected/known, unilateral, closed long bone fracture.
详细描述
This study is designed to evaluate the analgesic efficacy of TRV130 for the treatment of moderate to severe acute pain associated with a long bone fracture in patients presenting to the ED. The safety and tolerability of TRV130 will also be evaluated in this open-label pilot study.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years, inclusive
- •Has a suspected/known, unilateral, closed fracture of either: radius, ulna (or both) OR tibia, fibula (or both) BUT not fractures in more than 1 extremity
- •Able to understand and comply with study procedures and requirements, and provide written informed consent
排除标准
- •Significant concomitant head, chest, or abdominal trauma
- •Multiple extremity trauma
- •Open fracture
- •Clinically significant medical condition or history of such condition that may place the patient at an unacceptable risk in the trial, may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs
研究组 & 干预措施
TRV130
Drug: TRV130
干预措施: TRV130 (Drug)
结局指标
主要结局
Proportion of Patients Achieving Clinical Response, Defined as Achieving a NPRS <= 3, Without Requiring Rescue Pain Medication.
时间窗: 3-hours
Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours
次要结局
- Time Weighted Average Change in NPRS(From baseline to 30 minutes, to 1 hour, to 2 hours and to 3 hours)
- Time to First NPRS <= 3(3-hours)
- Safety Assessments(3-hours)