NCT07185594招募中2 期
A Phase Ⅱ/Ⅲ Study to Evaluate the Efficacy and Safety of HRS-2129 for Postsurgical Pain Management in Abdominal Surgery
Shandong Suncadia Medicine Co., Ltd.2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2025年10月24日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- The time-weighted sum of differences in resting pain intensity within 48 hours after the start of administration of the investigational product.
研究概览
简要总结
This is a phase II/III, multi-center, randomized, double-blind, comparator-controlled study to evaluate the efficacy and safety of HRS-2129 for postoperative pain management in 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the informed consent form before initiating trial-related activities, fully understand the purpose and significance of this trial, and voluntarily comply with the trial procedures;
- •Scheduled to undergo abdominal surgery (laparotomy or laparoscopy) under general anesthesia;
- •Aged ≥ 18 years (based on the date of signing the informed consent form), regardless of gender;
- •Body Mass Index (BMI) between 18.0 kg/m² and 30.0 kg/m² (inclusive);
- •American Society of Anesthesiologists (ASA) Physical Status Classification Grade I to II;
- •Within 6 hours after surgery (timed from the completion of the last suture), the subject has a Resting Pain Numeric Rating Scale (NRS) score ≥ 4 at any time point;
- •Male and female subjects of childbearing potential must agree to use effective contraceptive measures together with their partners from the time of signing the informed consent form until 1 month after the last administration of the investigational product, with no childbearing plans and no intention to donate sperm/eggs; Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days before the first administration (or within 2 days before surgery) and must not be breastfeeding.
排除标准
- •Subjects with a history of asthma, chronic urticaria, severe allergic reactions (see Appendix 13.11 for details), allergies to multiple (3 or more) drugs or foods, as well as a personal history or family history of hereditary angioedema before randomization;
- •Subjects with a history of new-onset myocardial infarction or unstable angina pectoris within 6 months before randomization, or a history of New York Heart Association (NYHA) Heart Failure Classification Grade II or higher;
- •Subjects with a history of arrhythmia requiring treatment before surgery;
- •Subjects who developed severe arrhythmia during surgery and were deemed unsuitable for participation in this study by the investigator;
- •Subjects with a history of malignant tumor within 5 years before randomization (except for cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma that has been completely resected and is clinically stable);
- •Subjects with a previous history of motion sickness, and the investigator judges that they may experience nausea and vomiting after surgery;
- •Subjects with a history of mental system diseases (such as schizophrenia, depression, etc.) and cognitive impairment before randomization;
- •Subjects with concurrent pain in various parts of the body, which the investigator believes may confuse the assessment of postoperative pain Subjects with a history of pheochromocytoma before randomization;
- •Subjects with concurrent conditions that the investigator believes may affect pain assessment, such as skin or neurological lesions in the affected skin area that may affect sensation;
- •Subjects with a previous surgical history at the surgical site;
- •QTc interval at screening: > 450 ms for males and > 470 ms for females (QTc calculated using the Fridericia formula); other electrocardiographic abnormalities that are clinically significant as judged by the investigator, which may affect the subject's safety or cause distress to the subject's participation in this clinical trial;
- •Subjects with hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) or hypotension (systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg) at screening, excluding abnormalities occurring during the period from entry into the operating room to exit from the recovery room;
- •Subjects with laboratory test abnormalities at screening;
- •Positive hepatitis B surface antigen (HBsAg) or positive hepatitis C virus antibody (HCV Ab) at screening (further testing for hepatitis B virus deoxyribonucleic acid (HBV DNA) titer or hepatitis C virus ribonucleic acid (HCV RNA) is required; subjects with results exceeding the detection limit of the assay must be excluded); positive human immunodeficiency virus antibody (HIV Ab); positive serum treponema pallidum antibody (TP Ab) (further testing for treponema pallidum titer is required; subjects with positive results must be excluded);
- •Participation in any other clinical study within 3 months before randomization;
- •Use of other drugs that affect analgesic efficacy before screening, where the time from the last dose to randomization is less than 5 times the drug's half-life;
- •Other circumstances where the investigator judges that the subject is unsuitable for participation in this clinical trial.
研究组 & 干预措施
HRS-2129 low-dose group
Experimental
干预措施: HRS-2129 Tablets (Drug)
HRS-2129 low-dose group
Experimental
干预措施: Blank Preparation. (Drug)
HRS-2129 middle-dose group
Experimental
干预措施: HRS-2129 Tablets (Drug)
HRS-2129 middle-dose group
Experimental
干预措施: Blank Preparation. (Drug)
HRS-2129 high-dose group
Experimental
干预措施: HRS-2129 Tablets (Drug)
HRS-2129 high-dose group
Experimental
干预措施: Blank Preparation. (Drug)
Blank preparation placebo group
Placebo Comparator
干预措施: Blank Preparation. (Drug)
Tramadol Hydrochloride SR Tablets group
Active Comparator
干预措施: Tramadol Hydrochloride SR Tablets (Drug)
结局指标
主要结局
The time-weighted sum of differences in resting pain intensity within 48 hours after the start of administration of the investigational product.
时间窗: Within 48 hours after the start of administration of the investigational product.
次要结局
- The time-weighted sums of differences in resting pain intensity at 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration (Sum of Pain Intensity Difference, SPID).(At 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration.)
- The time-weighted sums of differences in movement-related pain intensity at 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration.(At 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration.)
- Proportion of subjects with a reduction of ≥30%, ≥50%, and ≥70% in resting pain Numeric Rating Scales (NRS) scores from baseline at 24 hours and 48 hours after the first dose.(At 24 hours and 48 hours after the first dose.)
- Proportion of subjects with a reduction of ≥30%, ≥50%, and ≥70% in movement-related pain NRS scores from baseline at 24 hours and 48 hours after the first dose.(At 24 hours and 48 hours after the first dose.)
- Percentage of subjects who did not use rescue analgesics within 0-24 hours, 24-48 hours, and 0-48 hours after the first dose.(Within 0-24 hours, 24-48 hours, and 0-48 hours after the first dose.)
研究者
研究点 (2)
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