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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| morphine hydrochloride injection | Active Comparator |
| |
| LPM3480392 injection group 1 | Experimental |
| |
| LPM3480392 injection group 2 | Experimental |
| |
| LPM3480392 injection group 3 | Experimental |
| |
| LPM3480392 injection group 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LPM3480392 Injection | Drug | PCA administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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:
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);
Patients with abnormal liver and kidney function during screening period or before administration: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 1.5 times of normal value, total bilirubin higher than the upper limit of normal value, serum creatinine (Cr) > 1.5 times of the upper limit of normal value during screening period;
Subjects with coagulation abnormalities (PT prolonged more than 3 seconds above the upper limit of normal and/or activated partial thromboplastin time(APTT) prolonged more than 10 seconds above the upper limit of normal) during the screening period; and the investigator confirmed that the abnormalities were clinically significant;
History of drug abuse or drug abuse before screening;
Positive result in screening of drugs of abuse via urinalysis;
Nursing mothers;
Positive hepatitis B virus surface antigen (HBsAg) test [but the subject is eligible if the peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) is lower than the lower limit of the reference range, and the investigator believes that the subject is in a stable phase of chronic hepatitis B and will not increase the risk of the subject]; hepatitis C virus (HCV) antibody, treponema pallidum antibody, human immunodeficiency virus (HIV) antibody positive;
Participation in any medication (excluding vitamins and minerals) within 3 months prior to informed consent Quality) Clinical trial personnel, except for those not using investigational drugs;
subjects who are judged by the investigator to be not suitable for this clinical trial, including but not limited to the presence of conditions that may confound the interpretation of efficacy, safety, or tolerability data in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
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| Placebo | Drug | PCA administration |
|
| morphine hydrochloride injection | Drug | PCA administration |
|
| one day |
| Total number of compressions within 24 hours. | one day |
| Incidence and severity of adverse events within 24 h | one day |
| Sedation scale score | one day |
| Respiratory depression events (defined as respiratory rate ≤ 8 breaths/min and/or saturation < 90%) | one day |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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