A Phase 3, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Trevena Inc.
- 入组人数
- 407
- 试验地点
- 1
- 主要终点
- Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo.
研究概览
简要总结
The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute pain after abdominoplasty.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Has undergone abdominoplasty with no additional collateral procedures.
- •Experiences a pain intensity rating of moderate to severe acute pain.
- •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
Treatment 1 Oliceridine
干预措施: Oliceridine (Drug)
Treatment 2 Oliceridine
干预措施: Oliceridine (Drug)
Treatment 3 Oliceridine
干预措施: Oliceridine (Drug)
Treatment 4 Placebo
干预措施: Placebo (Drug)
Treatment 5 Morphine
干预措施: Morphine (Drug)
结局指标
主要结局
Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo.
时间窗: 24 hours
The NPRS is an 11-point scale from 0-10 where "0" = no pain and "10" = the most intense pain imaginable. A patient was a responder if: their final time-weighted Sum of Pain Intensity Difference (SPID)-24 corresponded to a ≥30% improvement without rescue pain medication during the Randomized Treatment Period, without early discontinuation of study medication for any reason, and without reaching the study medication dosing limit.
次要结局
- Number of Respiratory Safety Events Compared to Morphine.(24 hours)
- Duration of Respiratory Events Compared to Morphine.(24 hours)
- Odds Ratio of Patients Who Respond to Study Medication at the 24-hr NPRS Assessment Compared to Morphine.(24 hours)
- Number of Patients With Treatment-related Adverse Events Compared to Placebo and Compared to Morphine.(24 hours)