NCT07442877已完成2 期
A Multi-Center, Randomized, Double-Blind, Placebo/Active-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK21542 Injection for Postoperative Pain Treatment in Orthopedic Surgery
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Sum of Pain Intensity Differences (SPID)
研究概览
简要总结
This is a multi-center, randomized, double-blind, placebo/active-controlled study. 160 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK21542 group, morphine group, and placebo group.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old ≤ age ≤74 years old, regardless of gender;
- •18 kg/m2≤BMI≤32 kg/m2, meet the weight range specified in the protocol;
- •American Society of Anesthesiologists (ASA) grade 1-3;
- •Accept hip replacement under general anesthesia;
- •Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time;
- •Fully understand and voluntarily participate this trial, and sign the informed consent form;
排除标准
- •Patients with allergy to opioids or any component of the trial drug;
- •Patients with a history of severe cardiovascular and cerebrovascular diseases, ,and psychiatric disorders;
- •Last use of opioid or non-opioid analgesics less than 5 half-lives or the duration of drug efficacy prior to randomization; use of drugs with unclear half-lives that may affect analgesic efficacy within 7 days prior to randomization, or last use of drugs affecting analgesic efficacy less than 5 half-lives prior to randomization, as well as Chinese herbal medicines or proprietary Chinese medicines deemed by the investigator as potentially impacting the evaluation of efficacy and safety;
- •Continuous use of opioid analgesics for more than 7 days for any reason within 30 days prior to screening;
- •Laboratory test results during the screening period meeting any of the following criteria: 1) Significantly abnormal hematology results; 2) Significantly abnormal prothrombin time test results; 3) Significantly abnormal liver or kidney function; 4) Significantly abnormal fasting blood glucose;
- •Positive test results during the screening period for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody;
- •A history of drug, drug, and/or alcohol abuse
- •Participate in any clinical trail within 30 days;
- •Pregnant or lactating female subjects;
- •Subjects of childbearing potential who are unwilling to use contraception throughout the study period or plan to become pregnant within 3 months after the study.
- •Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.
研究组 & 干预措施
Placebo control
Placebo Comparator
Patients administrated with placebo
干预措施: Placebo (Drug)
Actice control
Active Comparator
Patients administrated with morphine
干预措施: morphine (Drug)
HSK21542 dose level 1
Experimental
Patients administrated with HSK21542 dose level 1
干预措施: HSK21542 dose level 1 (Drug)
HSK21542 dose level 2
Experimental
Patients administrated with HSK21542 dose level 2
干预措施: HSK21542 dose level 2 (Drug)
结局指标
主要结局
Sum of Pain Intensity Differences (SPID)
时间窗: 48 hours
Sum of Pain Intensity Differences (SPID) of each group
次要结局
- Sum of Pain Intensity Differences (SPID) in other time frame(0-8 hours, 0-24 hours, 24-48 hours)
- Number of times rescue analgesic medications were administered.(48 hours)
- Total morphine consumption(48 hours)
- Proportion of subjects experiencing nausea and/or vomit(48 hours)
研究者
研究点 (1)
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