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Phase II Clinical Trial to Evaluate the Efficacy and Safety of LPM3480392 Injection for Moderate to Severe Pain After Orthopedic Surgery

ConditionPain, Postoperative
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLuye Pharma Group Ltd.

About this trial

A randomized, double-blind, placebo/positive drug parallel controlled design was used to evaluate the preliminary efficacy and safety of intravenous infusion of LPM3480392 injection using different dosing regimens in subjects with moderate to severe pain after Orthopedic surgery

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily signed informed consent form (ICF) and comply with the trial procedures before starting the trial-related activities;

Over 18 years old , male or female;

Body mass index (BMI) 18-28 kg/m2 (including the boundary value)；

Subjects who plan to undergo unilateral total knee replacement or unilateral knee ligament reconstruction under general anesthesia; ;

Disqualifiers

Known history of allergy to any component of the investigational product, or allergy or contraindication to the anesthetic/analgesic drugs used in the study;

History of stroke, cognitive dysfunction, or epilepsy (excluding convulsions caused by previous febrile convulsions in children);

History of difficult airway, such as obstructive sleep apnea syndrome, bronchial asthma, chronic respiratory diseases or other serious respiratory diseases;

Subjects with a history of myocardial infarction, angina pectoris, severe arrhythmia of degree II or above atrioventricular block, or New York Heart Association(NYHA) Class II or above within 6 months prior to screening;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Drug

    patient-controlled analgesia(PCA) administration

  • morphine hydrochloride injection

    Drug

    patient-controlled analgesia(PCA) administration

  • LPM3480392 Injection

    Drug

    patient-controlled analgesia(PCA) administration

  • LPM3480392 Injection

    Drug

    patient-controlled analgesia(PCA) administration

  • LPM3480392 Injection

    Drug

    patient-controlled analgesia(PCA) administration

  • LPM3480392 Injection

    Drug

    patient-controlled analgesia(PCA) administration

Treatment groups

150 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: PlaceboPlacebo comparator 1 intervention
Group B: morphine hydrochloride injectionActive comparator 1 intervention
Group C: LPM3480392 injection group 1Experimental treatment 1 intervention
Group D: LPM3480392 injection group 2Experimental treatment 1 intervention
Group E: LPM3480392 injection group 3Experimental treatment 1 intervention
Group F: LPM3480392 injection group4Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

SPID48

the Sum of Pain Intensity Differences in Pain Score from baseline Over 48 Hours

Time frame
48 hours

Secondary outcomes

1

Cumulative dose of rescue analgesic drugs

Time frame
48 hours
2

Incidence of adverse events

Time frame
48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Luye Pharma Group Ltd.

Lead sponsor

Source ClinicalTrials.gov
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