Status:
NOT_YET_RECRUITING
A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Orthopedic Surgery
Lead Sponsor:
Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Conditions:
Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary objective is to evaluate the analgesic efficacy and safety of IV YZJ-4729 Tartrate Injection in patients with acute postoperative pain following Orthopedic surgery
Eligibility Criteria
Inclusion
- Be able to understand the study purpose and cooperate with the study procedures of this trial, voluntarily provide written informed consent
- BMI≥18.0 kg/m2 and ≤28.0 kg/m2
- ASA I to II
- Experiences a pain intensity rating of moderate to severe acute pain following orthopedic surgery, with a pain intensity score of ≥4 on a Numeric Rating Scale (NRS) within 4 hours post-surgery
Exclusion
- Opioid allergy
- Nervous system diseases (e.g. epilepsy)
- Psychiatric disorders (e.g. depression)
- History of difficult airways
- Random blood glucose ≥11.1 mmol/L
- Subjects with systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg or systolic blood pressure \< 90 mmHg
- Abnormal pulse oxygen saturation (SpO2 \<92 %)
- Abnormal liver function or renal function
- Used agents that could affect the analgesic response
- Used agents that could affect drug metabolism
- Has previously participated in another YZJ-4729 clinical study
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06901830
Start Date
April 1 2025
End Date
November 1 2025
Last Update
March 30 2025
Active Locations (21)
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1
The Third Xiangya Hospital of Central South University
Changsha, China
2
Chengdu Second People's Hospital
Chengdu, China
3
Sichuan Provincial People's Hospital
Chengdu, China
4
The Third People's Hospital of Chengdu
Chengdu, China