Clinical trial NCT06890533: A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Abdominal Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Pain
Lead sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-24
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

1. Be able to understand the study purpose and cooperate with the study procedures of this trial, voluntarily provide written informed consent
2. Body mass index (BMI) ≥18 kg/m2 and ≤28 kg/m2.
3. ASA I - II
4. 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 Criteria:

1. Allergy to opioids and other medications that may be used during the trial.
2. Nervous system disorders (e.g. epilepsy)
3. Psychiatric disorders (e.g. depression)
4. History of difficult airways
5. Random blood glucose ≥11.1 mmol/L
6. Uncontrolled blood pressure \[e.g., hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg)，or hypotension(systolic blood pressure \<90 mmHg)\]
7. Abnormal pulse oxygen saturation (SpO2 \<90 %)
8. Abnormal liver function or renal function
9. Used agents that could affect the analgesic response
10. Used agents that could affect drug metabolism
11. Has previously participated in another YZJ-4729 clinical study

Primary outcomes:
measure: the Sum of Pain Intensity Differences Over 24 Hours at rest
timeFrame: 24 hours
Secondary outcomes:
measure: The Time to first using rescue analgesics
timeFrame: 24 hours
measure: The proportion of subjects using rescue analgesics
timeFrame: 24 hours
measure: The number of times for rescue analgesics using
timeFrame: 24 hours
measure: The cumulative dose used of rescue analgesics
timeFrame: 24 hours
measure: the resting Sum of Pain Intensity Differences Over 6、12、18、12-24 Hours
timeFrame: 24 hours
measure: the active Sum of Pain Intensity Differences Over 6、12、18、24、12-24 Hours
timeFrame: 24 hours
measure: Participant satisfaction scores for analgesia treatment
timeFrame: 24 hours
measure: Investigator satisfaction scores for analgesia treatment
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
city: Cangzhou
country: China
facility: Cangzhou People's Hospital
city: Ch'ang-ch'un
country: China
facility: The First Hospital of Jilin University
city: Changde
country: China
facility: Changde First People's Hospital
city: Changsha
country: China
facility: Changsha Hospital Affiliated to Hunan University
city: Changsha
country: China
facility: The Fourth Hospital OF Changsha
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Chengdu
country: China
facility: The Second People's Hospital of Chengdu
city: Chengdu
country: China
facility: The Third People's Hospital of Chengdu
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
city: Dalian
country: China
facility: Affiliated Zhongshan Hospital of Dalian University
city: Deyang
country: China
facility: Deyang People's Hospital
city: Dongguan
country: China
facility: Dongguan People's Hospital
city: Ganzhou
country: China
facility: Ganzhou People's Hospital
city: Guangyuan
country: China
facility: The First People's Hospital of Guangyuan
city: Guangzhou
country: China
facility: Guangdong Province Traditional Chinese Medical Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
city: Ha'erbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
city: Haikou
country: China
facility: Haikou People's Hospital
city: Hefei
country: China
facility: The Second People's Hospital of Hefei
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
city: Huzhou
country: China
facility: Huzhou Central Hospital
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
city: Liuzhou
country: China
facility: Liuzhou Workers' Hospital
city: Luoyang
country: China
facility: Luoyang Central Hospital
city: Ma'anshan
country: China
facility: Ma'anshan People's Hospital
city: Mianyang
country: China
facility: Mianyang Central Hospital
city: Nanchang
country: China
facility: JiangXi Provincial People's Hospital
city: Nanning
country: China
facility: The Second Nanning People's Hospital
city: Neijiang
country: China
facility: The Second People's Hospital of Neijiang
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
city: Qingdao
country: China
facility: Qingdao Central Hospital of Rehabilitation University
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital
city: Shanghai
country: China
facility: Shanghai Fourth People's Hospital
city: Taizhou
country: China
facility: Taizhou People's Hospital
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Wuhan Third Hospital
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
city: Yibin
country: China
facility: The Second People's Hospital of Yibin
city: Zhangzhou
country: China
facility: Zhangzhou Municipal of Fujian Province
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
Study officials:
References: