NCT06890533进行中（未招募）3 期
A Phase Ⅲ, Randomized, Double-Blind, Placebo- and Active-controlled Study of YZJ-4729 Tartrate Injection for the Treatment of Moderate to Severe Pain After Abdominal Surgery
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 560
- 试验地点
- 51
- 主要终点
- the Sum of Pain Intensity Differences Over 24 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 abdominal 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
- •Body mass index (BMI) ≥18 kg/m2 and ≤28 kg/m
- •Experiences a pain intensity rating of moderate to severe acute pain following abdominal surgery, with a pain intensity score of ≥4 on a Numeric Rating Scale (NRS) within 4 hours post-surgery
排除标准
- •Allergy to opioids and other medications that may be used during the trial.
- •Nervous system disorders (e.g. epilepsy)
- •Psychiatric disorders (e.g. depression)
- •History of difficult airways
- •Random blood glucose ≥11.1 mmol/L
- •Uncontrolled blood pressure [e.g., hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg)，or hypotension(systolic blood pressure <90 mmHg)]
- •Abnormal pulse oxygen saturation (SpO2 <90 %)
- •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
Active Comparator
Active Comparator
干预措施: Active Comparator: Morphine (Drug)
Experimental Group 1
Experimental
干预措施: Experimental: YZJ-4729 (Drug)
Experimental Group 2
Experimental
干预措施: Experimental: YZJ-4729 (Drug)
Placebo Comparator
Placebo Comparator
干预措施: Placebo Comparator: Saline (Drug)
结局指标
主要结局
the Sum of Pain Intensity Differences Over 24 Hours at rest
时间窗: 24 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 24 hours.
次要结局
- The Time to first using rescue analgesics(24 hours)
- The proportion of subjects using rescue analgesics(24 hours)
- The number of times for rescue analgesics using(24 hours)
- The cumulative dose used of rescue analgesics(24 hours)
- the resting Sum of Pain Intensity Differences Over 6、12、18、12-24 Hours(24 hours)
- the active Sum of Pain Intensity Differences Over 6、12、18、24、12-24 Hours(24 hours)
- Participant satisfaction scores for analgesia treatment(24 hours)
- Investigator satisfaction scores for analgesia treatment(24 hours)
研究者
研究点 (51)
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