A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Orthopedic Surgery
NCT ID: NCT06901830
Last Updated: 2025-03-30
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
PHASE2
150 participants
INTERVENTIONAL
2025-04-30
2025-11-30
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
YZJ-4729
Loading dose + demand dose
Experimental Group 2
YZJ-4729
Loading dose + demand dose
Experimental Group 3
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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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. BMI≥18.0 kg/m2 and ≤28.0 kg/m2
3. ASA I to II
4. 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 Criteria
2. Nervous system diseases (e.g. epilepsy)
3. Psychiatric disorders (e.g. depression)
4. History of difficult airways
5. Random blood glucose ≥11.1 mmol/L
6. Subjects with systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg or systolic blood pressure \< 90 mmHg
7. Abnormal pulse oxygen saturation (SpO2 \<92 %)
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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The Third Xiangya Hospital of Central South University
Changsha, , China
Chengdu Second People's Hospital
Chengdu, , China
Sichuan Provincial People's Hospital
Chengdu, , China
The Third People's Hospital of Chengdu
Chengdu, , China
The First Hospital of Jilin University
Ch’ang-ch’un, , China
Dalian University Affiliated Zhongshan Hospital
Dalian, , China
Dongguan People's Hospital
Dongguan, , China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, , China
The Second People's Hospital of Hefei
Hefei, , China
Jinhua Central Hospital
Jinhua, , China
Mianyang Central Hospital
Mianyang, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
Zhongda Hospital Southeast University
Nanjing, , China
Ningbo Medical Center Lihuili Hospital
Ningbo, , China
The First Affiliated Hospital of Ningbo University
Ningbo, , China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, , China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Shanghai First People's Hospital
Shanghai, , China
The Third Hospital of Hebei Medical University
Shijiazhuang, , China
Suzhou University Affiliated Second Hospital
Suzhou, , China
Henan Provincial People's Hospital
Zhengzhou, , China
Countries
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Central Contacts
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Facility Contacts
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xiaoxue tang
Role: primary
xiaoyu chen
Role: primary
Other Identifiers
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YZJ-4729-2-02
Identifier Type: -
Identifier Source: org_study_id
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