Clinical Study of HRS-2129 for Postoperative Analgesia in Orthopaedics

November 14, 2025 updated by: Shandong Suncadia Medicine Co., Ltd.

Clinical Study on Safety and Efficacy of HRS-2129 for Postoperative Analgesiain Orthopaedics

The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for Postoperative analgesia in orthopaedics. To explore the reasonable dosage of HRS-2129 for Postoperative analgesia in orthopaedics.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

195

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
        • Principal Investigator:
          • Mengchang Yang
        • Principal Investigator:
          • Qian Lei

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Able and willing to provide a written informed consent
  2. Subjects requiring elective orthopedic surgery
  3. Conform to the ASA Physical Status Classification

Exclusion Criteria:

  1. Subjects with a history of severe allergies
  2. Subjects with nervous system disease
  3. Subjects with a history of mental illness
  4. Subjects with abnormal liver and renal function
  5. Subjects with poorly controlled hypertensive or hypotensive
  6. QTc：>450ms（male），>470ms（female）
  7. Subjects who screened positive for substance abuse
  8. History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
  9. The investigators determined that other conditions were inappropriate for participation in this clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group: low\middle\high-dose
HRS-2129； HRS-2129 placebo
Drug: HRS-2129
HRS-2129
Drug: HRS-2129 placebo
HRS-2129 placebo
Experimental: Treatment group:placebo
HRS-2129 placebo
Drug: HRS-2129 placebo
HRS-2129 placebo
Active Comparator: Treatment group: positive control
Tramadol Hydrochloride SR Tablets
Drug: Tramadol Hydrochloride SR Tablets
Tramadol Hydrochloride SR Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety：Incidence and severity of AE/SAE
Time Frame: from ICF signing date to day 12 since last dose(14 days)
from ICF signing date to day 12 since last dose(14 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Cmax
Time Frame: 5 days
5 days
Tmax
Time Frame: 5 days
5 days
the Sum of Pain Intensity Differences in Pain Score Over 6hour、12hour、16hour、24hour、48hour、12hour-24hour、24hour-48hour under static and moving condition
Time Frame: 48hours
48hours
The response rate of NRS scores under static and moving condition at 24hour and 48hour after the first dose of medication
Time Frame: 48hours
48hours
Participant ' satisfaction score for analgesia treatment
Time Frame: 48hours
48hours
Investigator satisfaction score for analgesia treatment
Time Frame: 48hours
48hours
Time of first use of remedial analgesic medication
Time Frame: 48hours
48hours
Cumulative use of remedial analgesics
Time Frame: 48hours
48hours
AUC0-12h
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

January 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS-2129-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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