A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Orthopedic Surgery

Phase 2

Not yet recruiting

• Conditions: Pain
• Interventions: Drug: YZJ-4729

• Registration Number: NCT06901830
• Lead Sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Study Start: 2025-04
• Primary Completion: 2025-10
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group 1	YZJ-4729	-
Experimental Group 2	YZJ-4729	-
Experimental Group 3	YZJ-4729	-

Primary Outcome Measures

Name	Time	Method
The sum of pain intensity differences in pain score over 48 hours at rest	48 hours	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.

Secondary Outcome Measures

Name	Time	Method
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	48 hours	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
Investigator satisfaction scores for analgesia treatment	48 hours	Postoperative analgesia was evaluated by investigators. The scale ranges from 1 to 5, with 1 being dissatisfied and 5 being very satisfied

Trial Locations

Locations (21)

The First Hospital of Jilin University; 🇨🇳 Ch'ang-ch'un, China

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

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