A Phase 2, Multicenter, Randomized, Double-blind, Multiple-dose, Adaptive, Placebo- and Active-controlled Study of TRV130 for the Treatment of Acute Postoperative Pain After Bunionectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Trevena Inc.
- 入组人数
- 333
- 试验地点
- 3
- 主要终点
- Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo
研究概览
简要总结
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy.
详细描述
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy. The results section also includes data from the morphine arms.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.
- •Experiences a pain intensity rating of ≥ 4 on an 11 point NRS
- •Able to provide written informed consent before any study procedure.
排除标准
- •ASA Physical Status Classification System classification of P3 or worse
- •Has surgical or post-surgical complications.
- •Has clinically significant medical conditions or history of such conditions that 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.
- •Has previously participated in another TRV130 clinical study.
研究组 & 干预措施
TRV130 1 mg
TRV130 1 mg IV Q4H x 48 h
干预措施: TRV130 (Drug)
TRV130 2 mg
TRV130 2 mg IV Q4H x 48 h
干预措施: TRV130 (Drug)
TRV130 3 mg
TRV130 3 mg IV Q4H x 48 h
干预措施: TRV130 (Drug)
TRV130 4 mg
TRV130 4 mg IV Q4H x 48 h
干预措施: TRV130 (Drug)
Morphine
Morphine 4 mg IV Q4H x 48 h
干预措施: Morphine (Drug)
Placebo
Placebo (D5W) IV Q4H x 48 h
干预措施: Placebo (Drug)
结局指标
主要结局
Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo
时间窗: 48 hours
Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NPRS.
次要结局
未报告次要终点