Evaluating HRS-2129 for pain relief after orthopedic surgery
Clinical Study on Safety and Efficacy of HRS-2129 for Postoperative Analgesiain Orthopaedics
This study is testing a new pain relief medication called HRS-2129 to see if it helps people feel better after orthopedic surgery compared to a placebo.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 195 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shandong Suncadia Medicine Co., Ltd. Industry-sponsored |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06780267 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the safety and efficacy of HRS-2129 as a postoperative analgesic in patients undergoing elective orthopedic surgery. The trial will explore appropriate dosages of HRS-2129 compared to a placebo to determine its effectiveness in managing pain after surgery. Participants will be monitored for any adverse effects and overall pain relief. The study is designed to provide insights into a new pain management option for orthopedic patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults requiring elective orthopedic surgery who can provide informed consent.
Not a fit: Patients with severe allergies, nervous system diseases, or significant cardiac issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new effective pain management solution for patients recovering from orthopedic surgery.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in postoperative pain management with novel analgesics.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chengdu, Sichuan
- Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Lei Tang
- Email: lei.tang.lt31@hengrui.com
- Phone: +0518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.