Actively Recruiting
Phase II Clinical Trial to Evaluate the Efficacy and Safety of LPM3480392 Injection for Moderate to Severe Pain After Orthopedic Surgery
Led by Luye Pharma Group Ltd. · Updated on 2024-06-21
150
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Phase II Clinical Trial to Evaluate the Efficacy and Safety of LPM3480392 Injection for Moderate to Severe Pain After Orthopedic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent and agree to follow study procedures
- Age 18 years or older, any gender
- Body mass index (BMI) between 18 and 28 kg/m2
- Planned unilateral total knee replacement or knee ligament reconstruction under general anesthesia
- American Society of Anesthesiologists (ASA) grade I or II
- Female participants have a negative pregnancy test at screening
- Agree to use effective contraception during the study and for at least 1 month after treatment
- Numerical rating scale (NRS) score of 4 or higher at rest within 4 hours after surgery
You will not qualify if you...
- Allergy to any study drug components or anesthetic/analgesic drugs used in the trial
- History of stroke, cognitive dysfunction, or epilepsy (excluding childhood febrile convulsions)
- History of difficult airway, obstructive sleep apnea, asthma, or serious respiratory diseases
- History within 6 months of myocardial infarction, angina, severe arrhythmia, or NYHA Class II or above heart failure
- History of vestibular dysfunction or motion sickness
- Diabetes with glycosylated hemoglobin ≥9% at screening
- Esophagitis or paralytic gastrointestinal obstruction
- Other acute or chronic pain conditions affecting pain evaluation
- Use of opioid analgesics for over 10 days within 3 months prior or analgesic drugs within 5 half-lives before randomization
- Use of analgesic Chinese herbal or patent medicine within 48 hours prior to randomization
- Systolic blood pressure <90 or >160 mmHg, diastolic blood pressure ≥60 mmHg at screening
- Oxygen saturation (SpO2) below 92% at screening
- Corrected QT interval (QTc) >450 ms for males, >460 ms for females at screening
- Abnormal liver or kidney function during screening
- Coagulation abnormalities with clinically significant prolongation
- History or current drug abuse
- Positive drug abuse screening in urine
- Lactating mothers
- Positive hepatitis C, syphilis, or HIV antibody tests
- Participation in other drug trials within 3 months prior to consent
- Investigator judgment of unsuitability for participation based on conditions affecting study data interpretation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Actively Recruiting
Research Team
X
xiangdong chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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