A Phase II/Ⅲ, Randomized, Double-Blind, Dose-explored, Active-controlled Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- the Sum of Pain Intensity Differences in Pain Score Over 48 Hours in the rest state
研究概览
简要总结
The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with morphine and placebo in patients with acute postoperative pain following orthopedic surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent
- •Subjects requiring elective general anesthesia orthopedic surgery
- •Conform to the ASA Physical Status Classification
排除标准
- •Subjects with a history of difficult airway
- •Subjects with a history of reflux esophagitis
- •Subjects with a history of mental illness
- •Subjects with poor blood pressure control
- •Transcutaneous oxygen saturation (SpO2) <90%
- •Random blood glucose ≥11.1mmol/L
- •Subjects with abnormal liver function
- •allergies to opioids and other medications that may be used during the trial
研究组 & 干预措施
Treatment group A：SHR8554 Injection
干预措施: SHR8554 Injection (Drug)
Treatment group B：SHR8554 Injection
干预措施: SHR8554 Injection (Drug)
Treatment group C：Saline Solution
干预措施: Saline Solution (Drug)
Treatment group D：Morphine
干预措施: Morphine (Drug)
结局指标
主要结局
the Sum of Pain Intensity Differences in Pain Score Over 48 Hours in the rest state
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
- Cumulative use of remedial analgesics from 0h to 48h(48-hours)
- Investigator satisfaction score for analgesia treatment(48-hours)
- Time of first use of remedial analgesic medication(48-hours)
- Participant ' satisfaction score for analgesia treatment(48-hours)
- the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、 48 、12-24、24-48 Hours under static and moving condition(48-hours)