Postoperative Analgesia
Conditions
Brief summary
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.
Interventions
DRUGHRS-2129 Tablets
HRS-2129 tablets.
DRUGBlank Preparation.
Blank preparation.
Tramadol Hydrochloride SR tablets.
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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; 2. Scheduled to undergo abdominal surgery (laparotomy or laparoscopy) under general anesthesia; 3. Aged ≥ 18 years (based on the date of signing the informed consent form), regardless of gender; 4. Body Mass Index (BMI) between 18.0 kg/m² and 30.0 kg/m² (inclusive); 5. American Society of Anesthesiologists (ASA) Physical Status Classification Grade I to II; 6. 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; 7. 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.
Exclusion criteria
1. 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; 2. 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; 3. Subjects with a history of arrhythmia requiring treatment before surgery; 4. Subjects who developed severe arrhythmia during surgery and were deemed unsuitable for participation in this study by the investigator; 5. 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); 6. Subjects with a previous history of motion sickness, and the investigator judges that they may experience nausea and vomiting after surgery; 7. Subjects with a history of mental system diseases (such as schizophrenia, depression, etc.) and cognitive impairment before randomization; 8. 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; 9. 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; 10. Subjects with a previous surgical history at the surgical site; 11. 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; 12. 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; 13. Subjects with laboratory test abnormalities at screening; 14. 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); 15. Participation in any other clinical study within 3 months before randomization; 16. 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; 17. Other circumstances where the investigator judges that the subject is unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time-weighted sum of differences in resting pain intensity within 48 hours after the start of administration of the investigational product. | Within 48 hours after the start of administration of the investigational product. |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Countries
China
Contacts
Primary ContactLei Tang
Outcome results
None listed