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

NCT07185594 | Recruiting Phase 2

• 1 other identifier: HRS-2129-301
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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).

  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.

Study Arms (5)

HRS-2129 low-dose group

EXPERIMENTAL

Drug: HRS-2129 Tablets; Drug: Blank Preparation.

HRS-2129 middle-dose group

EXPERIMENTAL

Drug: HRS-2129 Tablets; Drug: Blank Preparation.

HRS-2129 high-dose group

EXPERIMENTAL

Drug: HRS-2129 Tablets; Drug: Blank Preparation.

Blank preparation placebo group

PLACEBO COMPARATOR

Drug: Blank Preparation.

Tramadol Hydrochloride SR Tablets group

ACTIVE COMPARATOR

Drug: Tramadol Hydrochloride SR Tablets

Interventions

HRS-2129 Tablets DRUG

HRS-2129 tablets.

HRS-2129 high-dose group; HRS-2129 low-dose group; HRS-2129 middle-dose group

Blank Preparation. DRUG

Blank preparation.

Blank preparation placebo group; HRS-2129 high-dose group; HRS-2129 low-dose group; HRS-2129 middle-dose group

Tramadol Hydrochloride SR Tablets DRUG

Tramadol Hydrochloride SR tablets.

Tramadol Hydrochloride SR Tablets group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (2)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Central Study Contacts

Lei Tang

CONTACT

+86-0518-82342973; lei.tang.lt31@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: October 24, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-10

Locations

CN (2)