A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Orthopedic Surgery
A PhaseⅡ, Randomized, Double-Blind, Placebo- and Active- Controlled Study of YZJ-4729 Tartrate Injection for the Treatment of Moderate to Severe Pain After Orthopedic Surgery
1 other identifier
interventional
150
1 country
21
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 Orthopedic surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 pain
Started Apr 2025
Shorter than P25 for phase_2 pain
21 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 24, 2025
CompletedFirst Posted
Study publicly available on registry
March 30, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedMarch 30, 2025
March 1, 2025
6 months
March 24, 2025
March 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The sum of pain intensity differences in pain score over 48 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 48 hours.
48 hours
Secondary Outcomes (8)
The time of first using of rescue analgesics
0-48 hours
The proportion of subjects using rescue analgesics
0-48 hours
The number of times for rescue analgesics using
0-48 hours
The cumulative dose used of rescue analgesics
0-48 hours
The resting Sum of Pain Intensity Differences Over 12,24,24~48
0-48 hours
- +3 more secondary outcomes
Study Arms (5)
Experimental Group 1
EXPERIMENTALExperimental Group 2
EXPERIMENTALExperimental Group 3
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
- BMI≥18.0 kg/m2 and ≤28.0 kg/m2
- ASA I to II
- 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
You may not qualify if:
- Opioid allergy
- Nervous system diseases (e.g. epilepsy)
- Psychiatric disorders (e.g. depression)
- History of difficult airways
- Random blood glucose ≥11.1 mmol/L
- Subjects with systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg or systolic blood pressure \< 90 mmHg
- Abnormal pulse oxygen saturation (SpO2 \<92 %)
- 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 (21)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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 24, 2025
First Posted
March 30, 2025
Study Start
April 1, 2025
Primary Completion
October 1, 2025
Study Completion
November 1, 2025
Last Updated
March 30, 2025
Record last verified: 2025-03