A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Abdominal Surgery
A Phase Ⅲ, Randomized, Double-Blind, Placebo- and Active-controlled Study of YZJ-4729 Tartrate Injection for the Treatment of Moderate to Severe Pain After Abdominal Surgery
1 other identifier
interventional
560
1 country
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pain
Started Apr 2025
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2025
CompletedFirst Posted
Study publicly available on registry
March 24, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
March 24, 2025
March 1, 2025
1.2 years
March 11, 2025
March 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
the Sum of Pain Intensity Differences Over 24 Hours at rest
Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NRS), with higher numbers indicating a higher pain intensity, administered over 24 hours.
24 hours
Secondary Outcomes (8)
The Time to first using rescue analgesics
24 hours
The proportion of subjects using rescue analgesics
24 hours
The number of times for rescue analgesics using
24 hours
The cumulative dose used of rescue analgesics
24 hours
the resting Sum of Pain Intensity Differences Over 6、12、18、12-24 Hours
24 hours
- +3 more secondary outcomes
Study Arms (4)
Experimental Group 1
EXPERIMENTALExperimental Group 2
EXPERIMENTALPlacebo Comparator
PLACEBO COMPARATORActive Comparator
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Cangzhou Central Hospital
Cangzhou, China
Cangzhou People's Hospital
Cangzhou, China
Changde First People's Hospital
Changde, China
Changsha Hospital Affiliated to Hunan University
Changsha, China
The Fourth Hospital OF Changsha
Changsha, China
The Third Xiangya Hospital of Central South University
Changsha, China
Sichuan Provincial People's Hospital
Chengdu, China
The Second People's Hospital of Chengdu
Chengdu, China
The Third People's Hospital of Chengdu
Chengdu, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
The First Hospital of Jilin University
Ch’ang-ch’un, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, China
Deyang People's Hospital
Deyang, China
Dongguan People's Hospital
Dongguan, China
Ganzhou People's Hospital
Ganzhou, China
The First People's Hospital of Guangyuan
Guangyuan, China
Guangdong Province Traditional Chinese Medical Hospital
Guangzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
The First Affiliated Hospital of Jinan University
Guangzhou, China
Haikou People's Hospital
Haikou, China
The Fourth Affiliated Hospital of Harbin Medical University
Ha’erbin, China
The Second People's Hospital of Hefei
Hefei, China
The First Affiliated Hospital of University of South China
Hengyang, China
Huzhou Central Hospital
Huzhou, China
The First Hospital of Jiaxing
Jiaxing, China
Liuzhou People's Hospital
Liuchow, China
Liuzhou Workers' Hospital
Liuchow, China
Luoyang Central Hospital
Luoyang, China
Ma'anshan People's Hospital
Ma’anshan, China
Mianyang Central Hospital
Mianyang, China
JiangXi Provincial People's Hospital
Nanchang, China
The Second Nanning People's Hospital
Nanning, China
The Second People's Hospital of Neijiang
Neijiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, China
Qingdao Central Hospital of Rehabilitation University
Qingdao, China
Shanghai First Maternity and Infant Hospital
Shanghai, China
Shanghai Fourth People's Hospital
Shanghai, China
Taizhou People's Hospital
Taizhou, China
The Second Hospital of Tianjin Medical University
Tianjin, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Wuhan Third Hospital
Wuhan, China
Affiliated Hospital of Jiangnan University
Wuxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Zhongshan Hospital Xiamen University
Xiamen, China
The Second People's Hospital of Yibin
Yibin, China
Zhangzhou Municipal of Fujian Province
Zhangzhou, China
Henan Provincial People's Hospital
Zhengzhou, China
Zhuzhou Central Hospital
Zhuzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2025
First Posted
March 24, 2025
Study Start
April 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
March 24, 2025
Record last verified: 2025-03