NCT05394402终止2 期
A Phase Ⅱ, Randomized, Double-blind, Placebo-controlled ， Evaluation of the Safety, Efficacy of SHR0410 Injection for Pain Management Following Orthopaedic Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Usage of Morphine, Post Surgery
研究概览
简要总结
The study is being conducted to evaluate the efficacy, safety of SHR0410 Injection and to explore the reasonable of SHR0410 Injection for Pain Management after Orthopaedic 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；
- •Male or female；
- •Meet the body mass index standard；
- •Conform to the ASA Physical Status Classification；
- •Negative pregnancy test.
排除标准
- •Subjects with a history of myocardial infarction or unstable angina pectoris；
- •Subjects with atrioventricular block or cardiac insufficiency；
- •Subjects with a history of malignancy ；
- •Subjects with a history of stroke；
- •Subjects with a history of mental illness；
- •Subjects with a history of difficult airway；
- •Random blood glucose ≥11.1mmol/L；
- •Subjects with poor blood pressure control；
- •Abnormal values in liver or renal function；
- •Subject with a history of substance abuse and drug abuse；
- •Allergic to drugs that may be used during the study；
- •Use other drugs that affect the analgesic effect before randomization, and the time from the last use to randomization is shorter than 5 half-lives；
- •Participated in clinical trials of other drugs (received experimental drugs)；
- •Other circumstances that the investigator judged inappropriate for participation in this clinical trial.
研究组 & 干预措施
SHR0410 Injection High dose
Experimental
干预措施: SHR0410 Injection (Drug)
SHR0410 Injection Low dose
Experimental
干预措施: SHR0410 Injection (Drug)
Placebo for SHR0410 Injection
Placebo Comparator
干预措施: Placebo for SHR0410 Injection (Drug)
结局指标
主要结局
Usage of Morphine, Post Surgery
时间窗: 0 hour to 48 hours after IP administration
Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 48 hour period post IP administration
次要结局
- Time to First Dose of Rescue Analgesia(0 hour to 48 hours after IP administration)
- the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under moving condition(48-hours)
- Usage of Morphine, Post Surgery at other intervals(0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration)
- the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under static condition(48-hours)
- Frequency of Doses of Rescue Analgesia Utilized Per Subject， total consumption of morphine Rescue Analgesia Utilized Per Subject(0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration)
- Total press times of PCA pump and effective press times of PCA pump(0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration)
- Participant ' satisfaction score for analgesia treatment(48-hours)
- Proportion of subjects who did not receive Rescue Analgesia(0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration)
- Investigator satisfaction score for analgesia treatment(48-hours)
研究者
研究点 (1)
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