A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Abdominal Surgery
NCT ID: NCT06890533
Last Updated: 2025-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
560 participants
INTERVENTIONAL
2025-04-30
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental Group 1
Experimental: YZJ-4729
Loading dose + demand dose
Experimental Group 2
Experimental: YZJ-4729
Loading dose + demand dose
Placebo Comparator
Placebo Comparator: Saline
Loading dose + demand dose
Active Comparator
Active Comparator: Morphine
Loading dose + demand dose
Interventions
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Experimental: YZJ-4729
Loading dose + demand dose
Placebo Comparator: Saline
Loading dose + demand dose
Active Comparator: Morphine
Loading dose + demand dose
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Liuzhou, , China
Liuzhou Workers' Hospital
Liuzhou, , 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
Countries
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Central Contacts
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Other Identifiers
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YZJ-4729-3-01
Identifier Type: -
Identifier Source: org_study_id
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