A Phase Ⅱ/Ⅲ Study of HRS-2129 for Postsurgical Pain Management in Abdominal Surgery

Официальное название

A Phase Ⅱ/Ⅲ Study to Evaluate the Efficacy and Safety of HRS-2129 for Postsurgical Pain Management in Abdominal Surgery

Обзор

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.

Вмешательства

• Препарат HRS-2129 Tablets
  HRS-2129 tablets.
• Препарат Blank Preparation.
  Blank preparation.
• Препарат Tramadol Hydrochloride SR Tablets
  Tramadol Hydrochloride SR tablets.

Первичные конечные точки

• The time-weighted sum of differences in resting pain intensity within 48 hours after the start of administration of the investigational product. [Срок оценки: Within 48 hours after the start of administration of the investigational product.]

Вторичные конечные точки (5)

• 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). [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Within 0-24 hours, 24-48 hours, and 0-48 hours after the first dose.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07185594 · HRS-2129-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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