Clinical Study of HRS-2129 for Postoperative Analgesia in Orthopaedics

Phase 1

Recruiting

• Conditions: Postoperative Pain in Orthopaedics
• Interventions: Drug: HRS-2129; Drug: Tramadol Hydrochloride SR Tablets; Drug: HRS-2129 placebo

• Registration Number: NCT06780267
• Lead Sponsor: Shandong Suncadia Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Study First Posted: 2025-01-17
• Study Start: 2025-03-11
• Last Update Submitted: 2025-11-14
• Last Update Posted: 2025-11-18
• Primary Completion: 2026-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 195

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group: low\middle\high-dose	HRS-2129	HRS-2129； HRS-2129 placebo
Treatment group: low\middle\high-dose	HRS-2129 placebo	HRS-2129； HRS-2129 placebo
Treatment group:placebo	HRS-2129 placebo	HRS-2129 placebo
Treatment group: positive control	Tramadol Hydrochloride SR Tablets	Tramadol Hydrochloride SR Tablets

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Cumulative use of remedial analgesics	48hours
Tmax	5 days
AUC0-12h	5 days
Cmax	5 days

Trial Locations

Locations (1)

Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China