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Primary Objective: To explore the analgesic efficacy of YZJ-4729 compared with placebo in patients with acute postoperative pain following abdominal surgery.
Secondary Objective: To explore the analgesic efficacy and safety of YZJ-4729 compared with placebo and morphine in patients with acute postoperative pain following abdominal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1 | Experimental |
| |
| Treatment group 2 | Experimental |
| |
| Treatment group 3 | Experimental |
| |
| Treatment group 4 | Experimental |
| |
| Morphine | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YZJ-4729 | Drug | Dose Group 1 |
| |
| morphine |
| Measure | Description | Time Frame |
|---|---|---|
| The time-weighted sum of differences in resting state pain intensity over 24 hours (SPID24) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who did not use rescue analgesics within 0 to 24 hours | 0~24 hours | |
| The time-weighted sum of differences in resting state pain intensity over different perioid | 0-24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The total dose and times of rescue analgesics | 0-24 hours | |
| Time of first use of rescue analgesics for the first time | 0-24 hours | |
| The sum of resting state pain relief score over 24 hours |
Inclusion Criteria:
Exclusion Criteria:
Individuals with a known history of allergy to any component of the investigational drug, or with an allergy or contraindication to anesthetic/analgesic drugs used during surgery;
Patients with the following conditions or medical histories:
Hypertension that has not received regular antihypertensive treatment or is poorly controlled despite treatment: during the screening period, systolic blood pressure greater than 160 mmHg, or diastolic blood pressure greater than 100 mmHg (excluding abnormalities during the peri-anesthetic period).
Patients with a systolic blood pressure less than 90 mmHg during the screening period (excluding abnormalities during the peri-anesthetic period);
Peripheral capillary oxygen saturation (SpO2) <92% in a non-oxygen-supplemented state (excluding abnormalities during the peri-anesthetic period) at screening;
Clinically significantly abnormal electrocardiogram, including a QT interval corrected for heart rate (Fridericia; QTcF interval) of > 450 milliseconds in males and > 470 milliseconds in females, at screening.
Abnormal liver or kidney function at cscreening: (total bilirubin > upper limit of normal [ULN], aspartate aminotransferase [AST] >1.5 × ULN AND alanine aminotransferase [ALT] >1.5 × ULN, or serum creatinine (Cr) level g >1.5 × ULN;
Abnormal coagulation function: Prothrombin time (PT) prolonged by more than 3 seconds above the upper limit of normal and/or Activated Partial Thromboplastin Time (APTT) prolonged by more than 10 seconds above the upper limit of normal.
Positive for Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibodies (HCV-Ab), Treponema pallidum antibodies (for syphilis), and Human Immunodeficiency Virus antibodies (HIV-Ab).
Use of medications that affect postoperative analgesic effects before randomization:
Use of monoamine oxidase inhibitors (such as phenelzine, tranylcypromine, selegiline, pargyline, methamphetamine, etc.), selective serotonin reuptake inhibitors (SSRIs), selective serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or triptans within 14 days before randomization.
Use of moderate to severe inhibitors/inducers of the liver metabolic enzyme CYP3A4 within 14 days before randomization (such as: enzyme inhibitors - amiodarone, atazanavir, ketoconazole, clarithromycin, itraconazole, etc., enzyme inducers - rifampin, phenytoin sodium, phenobarbital, carbamazepine, etc.).
Participated in any clinical trial involving medication (excluding vitamins and minerals) within 3 months prior to screening, except those not involving investigational drugs;
History of drug abuse, alcohol poisoning/dependence, or drug misuse within 2 years prior to screening, or those with a positive urine drug screen during the screening period;
Women who are pregnant or breastfeeding;
Individuals who plan to conceive, are unwilling or unable to use effective contraceptive measures from the screening period to 3 months after the last use of the investigational product, or those who plan to donate sperm/eggs or have plans for egg freezing;
Subjects deemed unsuitable to participate in this clinical trial by the investigator.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | China |
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Multi center, randomized, double-blind, placebo-controlled, and positive drug parallel controls
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| Drug |
morphine, |
|
| placebo | Drug | placebo |
|
| YZJ-4729 | Drug | Dose Group 2 |
|
| YZJ-4729 | Drug | Dose Group 3 |
|
| YZJ-4729 | Drug | Dose Group 4 |
|
| Participant ' satisfaction score for analgesia treatment | 24 hours |
| Investigator satisfaction score for analgesia treatment | 24 hours |
| 6、12、18、24、12~24 hours |
| The total number of PCA compressions and the number of effective PCA compressions within 0-24 hours | 0-24 hours |
| Time to pain relief | 0-24 hours |
| The median time for the first improvement of at least 1 point on the NRS score | 0-24 hours |
| The time-weighted sum of differences in movement state pain intensity over different perioid | 6、12、18、24、12~24 hours |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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