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

NCT06467409 | Recruiting Phase 2

• 1 other identifier: LY03014/CT-CHN-204
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• SPID48

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

  48 hours

Secondary Outcomes (2)

• Cumulative dose of rescue analgesic drugs

  48 hours

• Incidence of adverse events

  48 hours

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

morphine hydrochloride injection

ACTIVE COMPARATOR

Drug: morphine hydrochloride injection

LPM3480392 injection group 1

EXPERIMENTAL

Drug: LPM3480392 Injection

LPM3480392 injection group 2

EXPERIMENTAL

Drug: LPM3480392 Injection

LPM3480392 injection group 3

EXPERIMENTAL

Drug: LPM3480392 Injection

LPM3480392 injection group4

EXPERIMENTAL

Drug: LPM3480392 Injection

Interventions

Placebo DRUG

patient-controlled analgesia(PCA) administration

Placebo

morphine hydrochloride injection DRUG

patient-controlled analgesia(PCA) administration

morphine hydrochloride injection

LPM3480392 Injection DRUG

patient-controlled analgesia(PCA) administration

LPM3480392 injection group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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; ;
• American Society of Anesthesiologists(ASA )grade I \~ II;
• Female subjects with a negative pregnancy test at Screening. Male and female subjects agree to take effective contraceptive measures throughout the study and for at least 1 month after medication;
• the numerical rating scale(NRS) score at rest was ≥ 4 points within 4 hours after surgery.

You may not qualify if:

• Known history of allergy to any component of the investigational product, or allergy or contraindication to the anesthetic/analgesic drugs used in the study;
• Had any of the following conditions or medical history:
• 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;
• History of vestibular dysfunction or motion sickness;
• Have a history of diabetes and glycosylated hemoglobin ≥ 9% during the screening period;
• Esophagitis;
• Paralytic gastrointestinal obstruction;
• The presence of other acute and chronic pain conditions preoperatively or in combination with other bodily pain conditions that confound the evaluation of postoperative pain.
• Medications affecting postoperative analgesia before randomization ：
• a) Opioid analgesics taken continuously for more than 10 days for any reason within 3 months prior to randomization, or taking drugs that involving analgesia prior to randomization and The time from last drug use to randomization is less than 5 half-lives( in accord with label ; unless t1/2 is unkown，execute according to 48h ) ,including but not limited to: ketamine, non-steroidal anti-inflammatory drugs (aspirin, acetaminophen, indomethacin, diclofenac, ibuprofen, parecoxib sodium, etc.), alpha adrenoceptor agonists (dexmedetomidine hydrochloride, clonidine, etc.), glucocorticoids (dexamethasone hydrochloride, hydrocortisone, methylprednisolone, etc., except for topical or topical use of glucocorticoids), antiepileptic drugs (carbamazepine, sodium valproate, etc.), sedative drugs (diazepam, estazolam, midazolam, alprazolam, barbiturate, phenobarbital and chloral hydrate, etc.); b. Use of Chinese herbal medicine or Chinese patent medicine which has the function of analgesia, sedation, antiemetic within 48h prior to randomization.
• Systolic blood pressure less than 90 mmHg or greater than 160 mmHg and diastolic blood pressure 60 mmHg or greater in screening phase;
• oxygen saturation by pulse oximetry(SpO2) \< 92% at screening ;
• Corrected QT interval(QTc )\> 450 ms for males and \> 460 m for females at screening ;

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

xiangdong chen

CONTACT

15071096621; xiangdongchen2013@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: June 21, 2024
• Study Start: January 26, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

CN (1)