Clinical Study of HRS-2129 for Postoperative Analgesia in Orthopaedics

NCT06780267 | Completed Phase 1

• 1 other identifier: HRS-2129-103
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain in Orthopaedics

Outcome Measures

Primary Outcomes (1)

• Safety：Incidence and severity of AE/SAE

  from ICF signing date to day 12 since last dose(14 days)

Secondary Outcomes (9)

• the Sum of Pain Intensity Differences in Pain Score Over 6hour、12hour、16hour、24hour、48hour、12hour-24hour、24hour-48hour under static and moving condition

  48hours

• The response rate of NRS scores under static and moving condition at 24hour and 48hour after the first dose of medication

  48hours

• Participant ' satisfaction score for analgesia treatment

  48hours

• Investigator satisfaction score for analgesia treatment

  48hours

• Time of first use of remedial analgesic medication

  48hours

Study Arms (3)

Treatment group: low\middle\high-dose

EXPERIMENTAL

HRS-2129； HRS-2129 placebo

Drug: HRS-2129; Drug: HRS-2129 placebo

Treatment group:placebo

EXPERIMENTAL

HRS-2129 placebo

Drug: HRS-2129 placebo

Treatment group: positive control

ACTIVE COMPARATOR

Tramadol Hydrochloride SR Tablets

Drug: Tramadol Hydrochloride SR Tablets

Interventions

HRS-2129 DRUG

HRS-2129

Treatment group: low\middle\high-dose

HRS-2129 placebo DRUG

HRS-2129 placebo

Treatment group: low\middle\high-dose; Treatment group:placebo

Tramadol Hydrochloride SR Tablets DRUG

Tramadol Hydrochloride SR Tablets

Treatment group: positive control

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: January 13, 2025
• First Posted: January 17, 2025
• Study Start: March 11, 2025
• Primary Completion: March 19, 2026
• Study Completion: April 3, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

CN (1)