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NCT Number: NCT06901830

A Study of YZJ-4729 Tartrate Injection for the Treatment of 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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Third Xiangya Hospital of Central South University, Changsha, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be able to understand the study purpose and cooperate with the study procedures of this trial, voluntarily provide written informed consent
  • BMI≥18.0 kg/m2 and ≤28.0 kg/m2
  • ASA I to II
  • 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

  • Opioid allergy
  • Nervous system diseases (e.g. epilepsy)
  • Psychiatric disorders (e.g. depression)
  • History of difficult airways
  • Random blood glucose ≥11.1 mmol/L
  • Subjects with systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg or systolic blood pressure < 90 mmHg
  • Abnormal pulse oxygen saturation (SpO2 <92 %)
  • Abnormal liver function or renal function
  • Used agents that could affect the analgesic response
  • Used agents that could affect drug metabolism
  • Has previously participated in another YZJ-4729 clinical study

Treatment and study plan

YZJ-4729

Drug

Loading dose + demand dose

Placebo Comparator: Saline

Drug

Loading dose + demand dose

Active Comparator: Morphine

Drug

Loading dose + demand dose

Primary outcomes

  1. The sum of pain intensity differences in pain score over 48 hours at rest

    Time frame: 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 outcomes

  1. The time of first using of rescue analgesics

    Time frame: 0-48 hours

  2. The proportion of subjects using rescue analgesics

    Time frame: 0-48 hours

  3. The number of times for rescue analgesics using

    Time frame: 0-48 hours

  4. The cumulative dose used of rescue analgesics

    Time frame: 0-48 hours

  5. The resting Sum of Pain Intensity Differences Over 12,24,24~48

    Time frame: 0-48 hours

  6. The active Sum of Pain Intensity Differences Over 12,24,48,24~48

    Time frame: 0-48 hours

  7. Participant satisfaction scores for analgesia treatment

    Time frame: 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

  8. Investigator satisfaction scores for analgesia treatment

    Time frame: 48 hours

    Postoperative analgesia was evaluated by investigators. The scale ranges from 1 to 5, with 1 being dissatisfied and 5 being very satisfied

Sponsors and collaborators

Lead sponsor

Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 30, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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