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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2025-11-30

Brief Summary

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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

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental Group 1

Group Type EXPERIMENTAL

YZJ-4729

Intervention Type DRUG

Loading dose + demand dose

Experimental Group 2

Group Type EXPERIMENTAL

YZJ-4729

Intervention Type DRUG

Loading dose + demand dose

Experimental Group 3

Group Type EXPERIMENTAL

YZJ-4729

Intervention Type DRUG

Loading dose + demand dose

Placebo Comparator

Group Type PLACEBO_COMPARATOR

Placebo Comparator: Saline

Intervention Type DRUG

Loading dose + demand dose

Active Comparator

Group Type ACTIVE_COMPARATOR

Active Comparator: Morphine

Intervention Type DRUG

Loading dose + demand dose

Interventions

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YZJ-4729

Loading dose + demand dose

Intervention Type DRUG

Placebo Comparator: Saline

Loading dose + demand dose

Intervention Type DRUG

Active Comparator: Morphine

Loading dose + demand dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Third Xiangya Hospital of Central South University

Changsha, , China

Site Status

Chengdu Second People's Hospital

Chengdu, , China

Site Status

Sichuan Provincial People's Hospital

Chengdu, , China

Site Status

The Third People's Hospital of Chengdu

Chengdu, , China

Site Status

The First Hospital of Jilin University

Ch’ang-ch’un, , China

Site Status

Dalian University Affiliated Zhongshan Hospital

Dalian, , China

Site Status

Dongguan People's Hospital

Dongguan, , China

Site Status

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, , China

Site Status

The Second People's Hospital of Hefei

Hefei, , China

Site Status

Jinhua Central Hospital

Jinhua, , China

Site Status

Mianyang Central Hospital

Mianyang, , China

Site Status

The First Affiliated Hospital of Nanchang University

Nanchang, , China

Site Status

Zhongda Hospital Southeast University

Nanjing, , China

Site Status

Ningbo Medical Center Lihuili Hospital

Ningbo, , China

Site Status

The First Affiliated Hospital of Ningbo University

Ningbo, , China

Site Status

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, , China

Site Status

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status

Shanghai First People's Hospital

Shanghai, , China

Site Status

The Third Hospital of Hebei Medical University

Shijiazhuang, , China

Site Status

Suzhou University Affiliated Second Hospital

Suzhou, , China

Site Status

Henan Provincial People's Hospital

Zhengzhou, , China

Site Status

Countries

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China

Central Contacts

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Xiaoyu Chen

Role: CONTACT

021-68383223

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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