Status:
NOT_YET_RECRUITING
A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Abdominal Surgery
Lead Sponsor:
Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Conditions:
Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 abdominal 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
- Body mass index (BMI) ≥18 kg/m2 and ≤28 kg/m2.
- ASA I - II
- Experiences a pain intensity rating of moderate to severe acute pain following abdominal surgery, with a pain intensity score of ≥4 on a Numeric Rating Scale (NRS) within 4 hours post-surgery
Exclusion
- Allergy to opioids and other medications that may be used during the trial.
- Nervous system disorders (e.g. epilepsy)
- Psychiatric disorders (e.g. depression)
- History of difficult airways
- Random blood glucose ≥11.1 mmol/L
- Uncontrolled blood pressure \[e.g., hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg)，or hypotension(systolic blood pressure \<90 mmHg)\]
- Abnormal pulse oxygen saturation (SpO2 \<90 %)
- 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 :
September 1 2026
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT06890533
Start Date
April 1 2025
End Date
September 1 2026
Last Update
March 24 2025
Active Locations (49)
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1
Cangzhou Central Hospital
Cangzhou, China
2
Cangzhou People's Hospital
Cangzhou, China
3
Changde First People's Hospital
Changde, China
4
Changsha Hospital Affiliated to Hunan University
Changsha, China