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

NCT06204120 | Completed Phase 2

• 1 other identifier: LY03014/CT-CHN-203
• 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 abdominal surgery.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• SPID24(the Sum of Pain Intensity Differences in Pain Score from baseline Over 24 Hours)

  Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours.

  one day

Secondary Outcomes (7)

• Cumulative dose of rescue analgesic drugs within 24 h

  one day

• Percentage of subjects not using rescue analgesic medication within 24 h

  one day

• Time of the first rescue analgesic drug

  one day

• Total number of compressions within 24 hours.

  one day

• Incidence and severity of adverse events within 24 h

  one day

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 group 4

EXPERIMENTAL

Drug: LPM3480392 Injection

Interventions

LPM3480392 Injection DRUG

PCA administration

LPM3480392 injection group 1; LPM3480392 injection group 2; LPM3480392 injection group 3; LPM3480392 injection group 4

Placebo DRUG

PCA administration

Placebo

morphine hydrochloride injection DRUG

PCA administration

morphine hydrochloride injection

Eligibility Criteria

• Age: 18 Years - 65 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;
• Aged 18-65 years (including the boundary value), male or female;
• Body mass index (BMI) 18-29 kg/m2 (including the boundary value), male body weight ≥ 50 kg; female body weight ≥ 45 kg;
• Subjects scheduled for elective abdominal surgery under general anesthesia, 1h ≤ duration of estimated surgery Interval ≤ 4h;
• American Society of Anesthesiologists（ASA ）grade I \~ II;
• Female subjects (not surgically sterile, surgical sterilization is defined as hysterectomy or oophorectomy) 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 investigator judges that the patient has recovered from intraoperative anesthesia to enough awake, which can be accurately completed the questionnaire was specified, and 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 opioid analgesics within 7 days prior to randomization; b） Use of the following drugs within 14 days prior to randomization, 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.); c） Use of Chinese herbal medicine or Chinese patent medicine within 7 days prior to randomization.
• Systolic blood pressure less than 90 mmHg or greater than 160 mmHg and diastolic blood pressure less than 1 day before surgery 60 mmHg or greater;
• Peripheral saturation (SpO2) \< 92% at screening or before administration;
• corrected QT interval（QTc ）\> 450 ms for males and \> 460 m for females at screening or pre-dose ( QTc is expressed as Fridericia formula calculation);

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

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

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: April 22, 2023
• First Posted: January 12, 2024
• Study Start: November 25, 2022
• Primary Completion: July 4, 2023
• Study Completion: July 4, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)