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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaoyu Chen; Phone Number: 021-68383223; Email: rjyljg_lx@163.com

Study Locations

• China
  • Ch'ang-ch'un, China
    • The First Hospital of Jilin University
  • Changsha, China
    • The Third Xiangya Hospital of Central South University
  • Chengdu, China
    • Sichuan Provincial People's Hospital
  • Chengdu, China
    • Chengdu Second People's Hospital
    • Contact: xiaoxue tang
  • Chengdu, China
    • The Third People's Hospital of Chengdu
  • Dalian, China
    • Dalian University Affiliated Zhongshan Hospital
  • Dongguan, China
    • Dongguan People's Hospital
  • Hangzhou, China
    • The First Affiliated Hospital of Zhejiang University School of Medicine
  • Hefei, China
    • The Second People's Hospital of Hefei
  • Jinhua, China
    • Jinhua Central Hospital
  • Mianyang, China
    • Mianyang Central Hospital
  • Nanchang, China
    • The First Affiliated Hospital of NanChang University
  • Nanjing, China
    • Zhongda Hospital Southeast University
  • Ningbo, China
    • Ningbo medical center lihuili hospital
  • Ningbo, China
    • The First Affiliated Hospital of Ningbo University
  • Quanzhou, China
    • The Second Affiliated Hospital of Fujian Medical University
  • Shanghai, China
    • Shanghai First People's Hospital
  • Shanghai, China
    • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Contact: xiaoyu chen
  • Shijiazhuang, China
    • The Third Hospital of Hebei Medical University
  • Suzhou, China
    • Suzhou University Affiliated Second Hospital
  • Zhengzhou, China
    • Henan Provincial People's 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. 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:

1. Opioid allergy
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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

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: YZJ-4729; Loading dose + demand dose
Experimental: Experimental Group 2	Drug: YZJ-4729; Loading dose + demand dose
Experimental: Experimental Group 3	Drug: 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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The active Sum of Pain Intensity Differences Over 12,24,48,24~48		0-48 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	48 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	48 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): October 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 24, 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-4729-2-02

Drug and device information, study documents

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