NCT07353307已完成3 期
To Evaluate the Efficacy, Safety and Pharmacokinetics of TRD303 Solution for Postoperative Analgesia After Abdominal Surgery in a Multicenter, Randomized, Double-blind, Placebo-positive Controlled Phase Ⅲ Clinical Trial
The Third Xiangya Hospital of Central South University2 个研究点 分布在 1 个国家目标入组 333 人开始时间: 2025年12月1日最近更新:
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
- 333
- 试验地点
- 2
- 主要终点
- Area under curve (AUC) of the pain intensity-time during 0-72h at rest
研究概览
简要总结
A multicenter, randomized, double-blind, placebo-positive, parallel-controlled, phase Ⅲ clinical trial of the efficacy, safety and pharmacokinetics of TRD303 solution for postoperative analgesia in patients undergoing abdominal surgery was conducted. The primary objective was to evaluate the efficacy of TRD303 solution for postoperative analgesia after abdominal surgery. The secondary objective was to evaluate the safety and pharmacokinetic profile of TRD303 solution for postoperative analgesia after abdominal 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully understand the purpose and significance of this study, voluntarily participate in this study, voluntarily sign the informed consent, and voluntarily abide by the process of this study;
- •18 years old ≤ age ≤80 years old, regardless of gender; 18.0kg/m2≤BMI≤30.0kg/m2, ≥50.0kg for men and ≥45.0kg for women;
- •4. American Society of Anesthesiologists (ASA) grade I-II (Appendix 1); (5) Elective abdominal surgery under general anesthesia, including laparoscopic or open surgery, and the length of the main incision is expected to be between 7±2cm (including the boundary value at both ends);
- •Can understand the research process and the use of various scales involved in this study, and can effectively communicate with researchers.
排除标准
- •Those who are known to have allergies or contraindications to ropivacaine or other amide local anesthetics, inactive ingredients of the investigational drug, or other drugs that may be used during the trial, and who are judged by the investigator to be unsuitable for the trial;
- •Use of the following drugs for less than 5 half-lives before randomization (according to the actual drug instructions, the half-life is unknown, or eluted according to 48 hours), including but not limited to: Class III antiarrhythmic drugs, glucocorticoids (systemic), anticonvulsants, sedative-hypnotic drugs, anxiolytic drugs, antidepressant drugs, CYP1A2 enzyme inhibitor, sedative drugs (except those used according to the protocol), analgesic drugs (except those used according to the protocol), the specific types refer to the list of prohibited drugs; Use of Chinese herbal medicine with definite analgesic effect assessed by investigators within 7 days before randomization;
- •Participants who planned to use hyperthermic perfusion, intraperitoneal chemotherapy, physical therapy, or other concomitant therapies during the treatment period that the investigator judged might affect postoperative pain;
- •patients who underwent abdominal surgery within 1 year before signing ICF;
- •patients who planned to undergo surgery at other sites during the study period;
- •Combined with other pain conditions that may confound the evaluation of postoperative pain according to the investigator;
- •Participants with a history of congenital or idiopathic methemoglobinemia or glucose-6-phosphate dehydrogenase deficiency;
- •Previous and/or family history of malignant hyperthermia;
- •Participants with poorly controlled blood pressure during screening (systolic blood pressure ≥160mmHg or ≤90 mmHg while sitting during screening, and/or diastolic blood pressure ≥100 mmHg or ≤60mmHg during screening, excluding abnormal blood pressure during anesthesia), whose abnormalities were judged by the investigator to be clinically significant and increase perioperative risk;
- •Heart rate < 50 beats/min or heart rate > 100 beats/min during screening (excluding abnormal heart rate during anesthesia), and the abnormal heart rate was judged by the investigator to be clinically significant; QTcF > 450ms in men and > 470ms in women [QTcF=QT/ (RR^0.33)]; Or a history of severe arrhythmias such as atrioventricular block of degree II or higher, or cardiac insufficiency;
- •Patients with severe liver, kidney, cardiovascular, cerebrovascular, or metabolic diseases judged by the investigator to be unsuitable for the trial;
- •Patients with advanced malignant tumors who were judged by the investigators to be not suitable for participating in the trial;
- •Patients with a history of mental diseases (such as schizophrenia, depression, etc.), dementia, migraine, or epilepsy, who were judged by the investigator to be unfit for the trial;
- •Patients with skin infection, ulceration or scar constitution around the incision, judged by the investigator to be not suitable for the trial;
- •Participants with a history of psychoactive and narcotic drug abuse, drug use, and heavy drinking (i.e., drinking an average of more than 2 units of alcohol per day (1 unit =360mL of beer or 45mL of 40% liquor or 150 ml of wine) in the year before randomization;
研究组 & 干预措施
Positive control group
Active Comparator
Before the surgical incision was closed, 0.5% ropivacaine hydrochloride was injected into the incision wound
干预措施: Ropivacaine hydrochloride (Drug)
Placebo control group
Placebo Comparator
Before the surgical incision was closed, the incision wound was infiltrated with 0.9% sodium chloride injection
干预措施: 0.9 % sodium chloride (Drug)
TRD303 group
Experimental
Before the surgical incision was closed, TRD303 solution was applied to the incision wound.
干预措施: TRD303 solution (Drug)
结局指标
主要结局
Area under curve (AUC) of the pain intensity-time during 0-72h at rest
时间窗: From administration until 72 hours after administration
Area under the resting pain intensity time curve (AUC0-72h) during 0-72 hours after administration
次要结局
- Area under the pain intensity time curve at rest(From administration until 4 hours, 6 hours, 12 hours, 24 hours, 48 hours after administration, from 24 hours to 48 hours after administration, from 48 hours to 72 hours after administration)
- Area under the pain intensity time curve during exercise(From the time of administration to 12 hours, 24 hours, 48 hours, 72 hours after administration, from 24 hours to 48 hours after administration, from 48 hours to 72 hours after administration)
- Time of first morphine rescue analgesia(From administration until 72 hours after administration)
- Cumulative use of rescue analgesics during each period(From the time of administration to 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after administration)
- The number of rescue analgesia in each period(From the time of administration to 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after administration)
- Proportion of rescue analgesia in each period(From the time of administration to 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after administration)
研究者
Yingyong Zhou,MD,PhD
PhD
The Third Xiangya Hospital of Central South University
研究点 (2)
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