Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Completed
NCT Number: NCT06780267
Clinical Study of HRS-2129 for Postoperative Analgesia in 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.
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Able and willing to provide a written informed consent
- Subjects requiring elective orthopedic surgery
- Conform to the ASA Physical Status Classification
Exclusion criteria
- 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
Treatment and study plan
HRS-2129
DrugHRS-2129
HRS-2129 Placebo
DrugHRS-2129 placebo
Tramadol Hydrochloride SR Tablets
DrugTramadol Hydrochloride SR Tablets
Primary outcomes
-
Safety：Incidence and severity of AE/SAE
Time frame: from ICF signing date to day 12 since last dose(14 days)
Secondary outcomes
-
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
-
The response rate of NRS scores under static and moving condition at 24hour and 48hour after the first dose of medication
Time frame: 48hours
-
Participant ' satisfaction score for analgesia treatment
Time frame: 48hours
-
Investigator satisfaction score for analgesia treatment
Time frame: 48hours
-
Time of first use of remedial analgesic medication
Time frame: 48hours
-
Cumulative use of remedial analgesics
Time frame: 48hours
-
Cmax
Time frame: 5 days
-
Tmax
Time frame: 5 days
-
AUC0-12h
Time frame: 5 days
Sponsors and collaborators
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Industry
Registry information
Official study title
Clinical Study on Safety and Efficacy of HRS-2129 for Postoperative Analgesiain Orthopaedics
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jan 17, 2025
- Registry last updated
- Jun 2, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Not Yet Recruiting
Effects of taVNS on Postoperative Pain in Complex Spinal Surgery
NCT07330973
Neurologic Manifestations, Pain
View Trial Details