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

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

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

Treatments tested in this trial

  • Placebo
  • morphine hydrochloride injection
  • LPM3480392 Injection
  • LPM3480392 Injection
  • LPM3480392 Injection
  • LPM3480392 Injection

Treatment groups

150 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators