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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain
• Intervention / Treatment: Drug: Experimental: YZJ-4729; Drug: Placebo Comparator: Saline; Drug: Active Comparator: Morphine

• Study Type: Interventional
• Enrollment (Estimated): 560
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Wen Ouyang; Phone Number: 0731-88618931; Email: ouyangwen139@126.com

Study Locations

• China
  • Cangzhou, China
    • Cangzhou Central Hospital
  • Cangzhou, China
    • Cangzhou People's Hospital
  • Ch'ang-ch'un, China
    • The First Hospital of Jilin University
  • Changde, China
    • Changde First People's Hospital
  • Changsha, China
    • The Third Xiangya Hospital of Central South University
  • Changsha, China
    • The Fourth Hospital of Changsha
  • Changsha, China
    • Changsha Hospital Affiliated to Hunan University
  • Chengdu, China
    • Sichuan Provincial People's Hospital
  • Chengdu, China
    • The Second People's Hospital of Chengdu
  • Chengdu, China
    • The Third People's Hospital of Chengdu
  • Chongqing, China
    • The First Affiliated Hospital of Chongqing Medical University
  • Chongqing, China
    • The Second Affiliated Hospital of Chongqing Medical University
  • Dalian, China
    • Affiliated Zhongshan Hospital of Dalian University
  • Deyang, China
    • Deyang People's Hospital
  • Dongguan, China
    • Dongguan People's Hospital
  • Ganzhou, China
    • Ganzhou People's Hospital
  • Guangyuan, China
    • The First People's Hospital of Guangyuan
  • Guangzhou, China
    • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  • Guangzhou, China
    • The First Affiliated Hospital of Jinan University
  • Guangzhou, China
    • Guangdong Province Traditional Chinese Medical Hospital
  • Ha'erbin, China
    • The Fourth Affiliated Hospital of Harbin Medical University
  • Haikou, China
    • Haikou People's Hospital
  • Hefei, China
    • The Second People's Hospital of Hefei
  • Hengyang, China
    • The First Affiliated Hospital of University of South China
  • Huzhou, China
    • Huzhou Central Hospital
  • Jiaxing, China
    • The First Hospital of Jiaxing
  • Liuzhou, China
    • Liuzhou Workers' Hospital
  • Liuzhou, China
    • Liuzhou people's Hospital
  • Luoyang, China
    • Luoyang Central Hospital
  • Ma'anshan, China
    • Ma'anshan People's Hospital
  • Mianyang, China
    • Mianyang Central Hospital
  • Nanchang, China
    • Jiangxi Provincial People's Hospital
  • Nanning, China
    • The Second Nanning People's Hospital
  • Neijiang, China
    • The Second People's Hospital of Neijiang
  • Ningbo, China
    • Ningbo medical center lihuili hospital
  • Qingdao, China
    • Qingdao Central Hospital of Rehabilitation University
  • Shanghai, China
    • Shanghai First Maternity and Infant Hospital
  • Shanghai, China
    • Shanghai Fourth People's Hospital
  • Taizhou, China
    • Taizhou People's Hospital
  • Tianjin, China
    • The Second Hospital Of Tianjin Medical University
  • Wuhan, China
    • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Wuhan, China
    • Wuhan Third Hospital
  • Wuxi, China
    • Affiliated Hospital of Jiangnan University
  • Xi'an, China
    • The First Affiliated Hospital of Xi'an Jiaotong University
  • Xiamen, China
    • Zhongshan Hospital Xiamen University
  • Yibin, China
    • The Second People's Hospital of Yibin
  • Zhangzhou, China
    • Zhangzhou Municipal of Fujian Province
  • Zhengzhou, China
    • Henan Provincial People's Hospital
  • Zhuzhou, China
    • ZhuZhou Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Comparator	Drug: Placebo Comparator: Saline; Loading dose + demand dose
Active Comparator: Active Comparator	Drug: Active Comparator: Morphine; Loading dose + demand dose
Experimental: Experimental Group 1	Drug: Experimental: YZJ-4729; Loading dose + demand dose
Experimental: Experimental Group 2	Drug: Experimental: YZJ-4729; Loading dose + demand dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
the active Sum of Pain Intensity Differences Over 6、12、18、24、12-24 Hours		24 hours
Participant satisfaction scores for analgesia treatment	Participants recalled the postoperative analgesia effect and rated their satisfaction on a scale of 1 to 5, with 1 representing dissatisfied and 5 representing very satisfied.	24 hours
Investigator satisfaction scores for analgesia treatment	Postoperative analgesia was evaluated by investigators. The scale ranges from 1 to 5, with 1 being dissatisfied and 5 being very satisfied.	24 hours

Collaborators and Investigators

• Sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: YZJ-4729-3-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No