NCT06901830已完成2 期
A PhaseⅡ, Randomized, Double-Blind, Placebo- and Active- Controlled Study of YZJ-4729 Tartrate Injection for the Treatment of Moderate to Severe Pain After Orthopedic Surgery
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 21
- 主要终点
- The sum of pain intensity differences in pain score over 48 hours at rest
研究概览
简要总结
The primary objective is to evaluate the analgesic efficacy and safety of IV YZJ-4729 Tartrate Injection 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able to understand the study purpose and cooperate with the study procedures of this trial, voluntarily provide written informed consent
- •BMI≥18.0 kg/m2 and ≤28.0 kg/m2
- •ASA I to II
- •Experiences a pain intensity rating of moderate to severe acute pain following orthopedic surgery, with a pain intensity score of ≥4 on a Numeric Rating Scale (NRS) within 4 hours post-surgery
排除标准
- •Opioid allergy
- •Nervous system diseases (e.g. epilepsy)
- •Psychiatric disorders (e.g. depression)
- •History of difficult airways
- •Random blood glucose ≥11.1 mmol/L
- •Subjects with systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg or systolic blood pressure < 90 mmHg
- •Abnormal pulse oxygen saturation (SpO2 <92 %)
- •Abnormal liver function or renal function
- •Used agents that could affect the analgesic response
- •Used agents that could affect drug metabolism
- •Has previously participated in another YZJ-4729 clinical study
研究组 & 干预措施
Experimental Group 1
Experimental
干预措施: YZJ-4729 (Drug)
Experimental Group 2
Experimental
干预措施: YZJ-4729 (Drug)
Experimental Group 3
Experimental
干预措施: YZJ-4729 (Drug)
Placebo Comparator
Placebo Comparator
干预措施: Placebo Comparator: Saline (Drug)
Active Comparator
Active Comparator
干预措施: Active Comparator: Morphine (Drug)
结局指标
主要结局
The sum of pain intensity differences in pain score over 48 hours at rest
时间窗: 48 hours
Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NRS), with higher numbers indicating a higher pain intensity, administered over 48 hours.
次要结局
- The time of first using of rescue analgesics(0-48 hours)
- The proportion of subjects using rescue analgesics(0-48 hours)
- The number of times for rescue analgesics using(0-48 hours)
- The cumulative dose used of rescue analgesics(0-48 hours)
- The resting Sum of Pain Intensity Differences Over 12,24,24~48(0-48 hours)
- The active Sum of Pain Intensity Differences Over 12,24,48,24~48(0-48 hours)
- Participant satisfaction scores for analgesia treatment(48 hours)
- Investigator satisfaction scores for analgesia treatment(48 hours)
研究者
研究点 (21)
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