NCT04852003已完成3 期
A Phase Ⅲ, Randomized, Double-blind, Placebo- and Active-controlled Study of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower Abdominal
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- The area under the curve of pain intensity over 24 hours
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after endoscopic surgery of the lower abdominal.
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 65 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 endoscopic surgery of the lower abdominal
- •Male or female
- •Meet the body mass index standard
- •Conform to the ASA Physical Status Classification
- •Exclusion Criteria
- •Subjects with a history of difficult airway
- •Subjects with a history of mental illness
- •Subjects with a history of cognitive impairment epilepsy
- •Subjects with a history of myocardial infarction or unstable angina pectoris
- •Subjects with atrioventricular block or cardiac insufficiency
- •Subjects with a history of ischemic stroke or transient ischemic attack
- •Subjects with poor blood pressure control after medication
- •Subject with a history of substance abuse and drug abuse
- •Abnormal values in liver function
- •Subjects with an oxygen saturation below 90% on room air
- •Allergic to drugs that may be used during the study
- •Pregnant or nursing women
- •No birth control during the specified period of time
- •Participated in clinical trials of other drugs (received experimental drugs)
- •The investigators determined that other conditions were inappropriate for participation in this clinical trial
排除标准
- 未提供
研究组 & 干预措施
SHR0410 Injection
Experimental
干预措施: SHR0410 Injection (Drug)
Placebo for SHR0410 Injection
Placebo Comparator
干预措施: Placebo (Drug)
Morphine
Active Comparator
干预措施: Morphine (Drug)
结局指标
主要结局
The area under the curve of pain intensity over 24 hours
时间窗: 24-hours
Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity, administered over 24 hours.
次要结局
- Total consumption of remedial analgesics from 0h to 24h(24-hours)
- Participant ' satisfaction score for analgesia treatment(24-hours)
- Investigator satisfaction score for analgesia treatment(24-hours)
- Frequency and severity of adverse events(Day 4（or early termination on Day 3）)
- Safety as assessed by vital signs(Day 4（or early termination on Day 3）)
- Safety as assessed by laboratory evaluations(Day 4（or early termination on Day 3）)
研究者
研究点 (1)
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