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This is a multi-center, randomized, double-blind, placebo/active-controlled study. 200 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK55718 group, morphine group, and placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK55718 dose level1 | Experimental |
| |
| HSK55718 dose level 2 | Experimental |
| |
| HSK55718 dose level 3 | Experimental |
| |
| Placebo control | Placebo Comparator |
| |
| morphine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK55718 dose level 1 | Drug | Patients administrated with HSK55718 at dose level 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Differences (SPID) | 48hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Differences (SPID) in other time frame | 0-12 hours, 12-24 hours, 24 hours, 24-48 hours | |
| Number of times rescue analgesic medications were administered. | 48 hours | |
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Inclusion Criteria:
Age ≥18 years old, regardless of gender; 18 kg/m2≤BMI≤30 kg/m2; American Society of Anesthesiologists (ASA) gradeⅰ-ⅲ; Accept abdominal surgery under general anesthesia; Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time; Fully understand and voluntarily participate this trial, and sign the informed consent form;
Exclusion Criteria:
A history of cardiovascular, respiratory, neurological, or psychiatric diseases that meet the protocol-defined exclusion criteria.
Clinically significant abnormalities in laboratory tests during the screening period.
A history of severe drug allergy or known allergy to the investigational drug. Continuous use of opioid analgesics for more than 10 days for any reason within 3 months prior to randomization.
Use of any medication that may affect analgesia, where the last dose was administered less than 5 half-lives of that drug before randomization.
A history of drug abuse, substance abuse, and/or alcohol abuse within the past year.
Pregnant or lactating women. Participation in another drug clinical trial within 3 months prior to the screening period.
Presence of any sensory dysfunction. Presence of any painful physical condition. Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongrui Wang | Contact | 028-67258779 | wangyr@haisco.com |
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| HSK55718 dose level 2 |
| Drug |
Patients administrated with HSK55718 at dose level 2 |
|
| HSK55718 dose level 3 | Drug | Patients administrated with HSK55718 at dose level 3 |
|
| placebo | Drug | Patients administrated with placebo |
|
| morphine | Drug | Patients administrated with morphine |
|
| Time to Pain Relief |
| 0-48 hours |
| Postoperative Analgesia Satisfaction Score | 48 hours |
| 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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