NCT07551739尚未招募2 期
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK55718 Injection for Postoperative Pain Treatment in Orthopedic Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 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. 200 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK55718 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old, regardless of gender; 18 kg/m2≤BMI≤30 kg/m2; American Society of Anesthesiologists (ASA) gradeⅰ-ⅲ; Accept abdominal surgery 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
- •A history of cardiovascular, respiratory, neurological, or psychiatric diseases that meet the protocol-defined exclusion criteria.
- •Clinically significant abnormalities in laboratory tests during the screening period.
- •A history of severe drug allergy or known allergy to the investigational drug. Continuous use of opioid analgesics for more than 10 days for any reason within 3 months prior to randomization.
- •Use of any medication that may affect analgesia, where the last dose was administered less than 5 half-lives of that drug before randomization.
- •A history of drug abuse, substance abuse, and/or alcohol abuse within the past year.
- •Pregnant or lactating women. Participation in another drug clinical trial within 3 months prior to the screening period.
- •Presence of any sensory dysfunction. Presence of any painful physical condition. Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.
研究组 & 干预措施
HSK55718 dose level1
Experimental
干预措施: HSK55718 dose level 1 (Drug)
HSK55718 dose level 2
Experimental
干预措施: HSK55718 dose level 2 (Drug)
HSK55718 dose level 3
Experimental
干预措施: HSK55718 dose level 3 (Drug)
Placebo control
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
Sum of Pain Intensity Differences (SPID)
时间窗: 48hours
次要结局
- Sum of Pain Intensity Differences (SPID) in other time frame(0-12 hours, 12-24 hours, 24 hours, 24-48 hours)
- Number of times rescue analgesic medications were administered.(48 hours)
- Time to Pain Relief(0-48 hours)
- Postoperative Analgesia Satisfaction Score(48 hours)
研究者
相似试验
已完成
2 期
A Phase 2 Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic SurgeryNCT07442877Haisco Pharmaceutical Group Co., Ltd.161
招募中
3 期
A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis.Plaque PsoriasisNCT07326813InventisBio Co., Ltd477
招募中
2 期
Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Pain Management in Abdominal SurgeryNCT07311369Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.40
招募中
2 期
A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Abdominal SurgeryPain After SurgeryNCT07533786Haisco Pharmaceutical Group Co., Ltd.200
招募中
不适用
A study to evaluate the effect of TruBlk™ Shilajit Resin on improving exercise performance, endurance, muscle strength, and recovery in males.CTRI/2025/07/091323Amaara Ayurveda100