NCT06780267已完成1 期
Clinical Study on Safety and Efficacy of HRS-2129 for Postoperative Analgesiain Orthopaedics
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2025年3月11日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Safety：Incidence and severity of AE/SAE
研究概览
简要总结
The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for Postoperative analgesia in orthopaedics. To explore the reasonable dosage of HRS-2129 for Postoperative analgesia in orthopaedics.
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 orthopedic surgery
- •Conform to the ASA Physical Status Classification
排除标准
- •Subjects with a history of severe allergies
- •Subjects with nervous system disease
- •Subjects with a history of mental illness
- •Subjects with abnormal liver and renal function
- •Subjects with poorly controlled hypertensive or hypotensive
- •QTc：>450ms（male），>470ms（female）
- •Subjects who screened positive for substance abuse
- •History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- •The investigators determined that other conditions were inappropriate for participation in this clinical trial
研究组 & 干预措施
Treatment group: low\middle\high-dose
Experimental
HRS-2129； HRS-2129 placebo
干预措施: HRS-2129 (Drug)
Treatment group: positive control
Active Comparator
Tramadol Hydrochloride SR Tablets
干预措施: Tramadol Hydrochloride SR Tablets (Drug)
Treatment group: low\middle\high-dose
Experimental
HRS-2129； HRS-2129 placebo
干预措施: HRS-2129 placebo (Drug)
Treatment group:placebo
Experimental
HRS-2129 placebo
干预措施: HRS-2129 placebo (Drug)
结局指标
主要结局
Safety：Incidence and severity of AE/SAE
时间窗: from ICF signing date to day 12 since last dose(14 days)
次要结局
- the Sum of Pain Intensity Differences in Pain Score Over 6hour、12hour、16hour、24hour、48hour、12hour-24hour、24hour-48hour under static and moving condition(48hours)
- The response rate of NRS scores under static and moving condition at 24hour and 48hour after the first dose of medication(48hours)
- Participant ' satisfaction score for analgesia treatment(48hours)
- Investigator satisfaction score for analgesia treatment(48hours)
- Time of first use of remedial analgesic medication(48hours)
- Cumulative use of remedial analgesics(48hours)
- Cmax(5 days)
- Tmax(5 days)
- AUC0-12h(5 days)
研究者
研究点 (1)
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