Clinical trial NCT06901830: A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Orthopedic Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Pain
Lead sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: The sum of pain intensity differences in pain score over 48 hours at rest
timeFrame: 48 hours
Secondary outcomes:
measure: The time of first using of rescue analgesics
timeFrame: 0-48 hours
measure: The proportion of subjects using rescue analgesics
timeFrame: 0-48 hours
measure: The number of times for rescue analgesics using
timeFrame: 0-48 hours
measure: The cumulative dose used of rescue analgesics
timeFrame: 0-48 hours
measure: The resting Sum of Pain Intensity Differences Over 12,24,24~48
timeFrame: 0-48 hours
measure: The active Sum of Pain Intensity Differences Over 12,24,48,24~48
timeFrame: 0-48 hours
measure: Participant satisfaction scores for analgesia treatment
timeFrame: 48 hours
measure: Investigator satisfaction scores for analgesia treatment
timeFrame: 48 hours
Other outcomes:
Locations:
city: Ch'ang-ch'un
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: Chengdu Second People's Hospital
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Chengdu
country: China
facility: The Third People's Hospital of Chengdu
city: Dalian
country: China
facility: Dalian University Affiliated Zhongshan Hospital
city: Dongguan
country: China
facility: Dongguan People's Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
city: Hefei
country: China
facility: The Second People's Hospital of Hefei
city: Jinhua
country: China
facility: Jinhua Central Hospital
city: Mianyang
country: China
facility: Mianyang Central Hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
city: Quanzhou
country: China
facility: The Second Affiliated Hospital of Fujian Medical University
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Shanghai First People's Hospital
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
city: Suzhou
country: China
facility: Suzhou University Affiliated Second Hospital
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
Study officials:
References: