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

Shanghai Haiyan Pharmaceutical Technology

Status and phase: Not yet enrolling; Phase 2

Conditions: Pain

Treatments: Drug: Active Comparator: Morphine; Drug: YZJ-4729; Drug: Placebo Comparator: Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT06901830

YZJ-4729-2-02

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 5 patient groups, including a placebo group

Experimental Group 1

Experimental group

Treatment:

Drug: YZJ-4729

Experimental Group 2

Experimental group

Treatment:

Drug: YZJ-4729

Experimental Group 3

Experimental group

Treatment:

Drug: YZJ-4729

Placebo Comparator

Placebo Comparator group

Treatment:

Drug: Placebo Comparator: Saline

Active Comparator

Active Comparator group

Treatment:

Drug: Active Comparator: Morphine