NCT04794738Unknown2 期
A Phase II/III, Randomized, Double-Blind, Placebo- and Active-controlled Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 192
- 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 placebo and morphine 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 70 Years（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
- •Pregnant or nursing women
研究组 & 干预措施
Treatment group A
Experimental
干预措施: SHR8554 (Drug)
Treatment group B
Experimental
干预措施: SHR8554 (Drug)
Treatment group C
Placebo Comparator
干预措施: Saline Solution (Drug)
Treatment group D
Active Comparator
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
- Time of first use of remedial analgesic medication(48-hours)
- the Sum of Pain Intensity Differences in Pain Score Over 6、12、48 、12-24、24-48 Hours under static condition(48-hours)
- the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under moving condition(48-hours)
- Cumulative use of remedial analgesics from 0h to 48h(48-hours)
- Participant ' satisfaction score for analgesia treatment(48-hours)
- Investigator satisfaction score for analgesia treatment(48-hours)
研究者
研究点 (1)
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