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This study is a multi-center, randomized, double-blind, placebo-controlled study. A total of 276 subjects undergoing elective laparoscopic surgery under general anesthesia are planned to be enrolled and randomized into 2 groups, i.e., the HSK21542 group (138 subjects) and the placebo group (138 subjects).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK21542 | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK21542 | Drug | HSK21542:1 µg/kg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Differences (SPID) | The time-weighted SPID at rest within 0-24 h after the first postoperative administration in each group | Frome administration until 24 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Differences (SPID) | The time-weighted SPID at rest within 0-12 h after the first postoperative administration in each group | Frome administration until 12 hours after administration |
| Use of remedial analgesics |
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Inclusion Criteria:
Exclusion Criteria:
With a history of allergy to opioids, such as urticaria, or allergic to intraoperative anesthetics as prescribed in the protocol;
Patients with history or evidence of any of the following diseases prior to screening:
In receipt of any one of the following medications or treatments at screening:
The laboratory parameters measured at screening period reach one of the following criteria:
Positive for hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody at screening;
History of medication or drug abuse and/or alcohol abuse within 3 months prior to screening (alcohol abuse is defined as an average of > 2 units of alcohol consumed per day [1 unit = 360 mL of beer with 5% alcohol, 45 mL of liquor with 40% alcohol, or 150 mL of wine]);
History of blood donation or blood loss of ≥ 400 mL within 3 months prior to screening;
Have participated in other clinical trials within 3 months prior to screening (defined as having received investigational product or placebo);
Pregnant or breastfeeding females; women of child-bearing potential or men who are unwilling to use contraception during the trial; or subjects who are planning pregnancy within 3 months after the completion of the trial (including male subjects);
Subject judged by the investigator to have any other factors unsuitable for involvement in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40413233 | Derived | Zhong Y, Xu Y, Lei Q, Yang M, Wang S, Hu X, Xie H, Li Y, Qin Z, Gu Z, Zhang J, Wang Y, Wu J, Wang H, Ming Y, Xia Z, Zhai H, Jiang K, Zhang P, Wang Z, Wang L, Li L, Cheng Z, Jiang H, Wang G, Chen J, Zhao Z, Chen X, Yan M. HSK21542 in patients with postoperative pain: two phase 3, multicentre, double-blind, randomized, controlled trials. Nat Commun. 2025 May 24;16(1):4830. doi: 10.1038/s41467-025-60013-y. |
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| Drug |
Placebo |
|
Cumulative used amount of remedial analgesics (morphine injection, mg) within 0-12 h or 0-24 h after the first postoperative administration in each group, percentage of subjects not using remedial analgesics, and start time of remedial analgesic use
| Frome administration until 24 hours after administration |
| Pain Intensity Differences(PID) | The PID at rest at each scoring time point after the first postoperative administration in each group | Frome administration until 24 hours after administration |
| The proportion of subjects with a NRS of ≤ 3 | The ratio of subjects with NRS score ≤ 3 at 12 h or 24 h after the first postoperative administration in each group | Frome administration until 24 hours after administration |
| Duration of analgesia | The duration of analgesia after the first postoperative administration in each group | Frome administration until 24 hours after administration |
| Satisfaction scores on postoperative analgesia | Subject satisfaction score and investigator satisfaction score on postoperative analgesia at 24 h after the first postoperative administration in each group | Frome administration until 24 hours after administration |
| The incidence and severity of AEs | Adverse event/serious adverse event | from signing the informed consent form to the follow-up period (D8 ± 1 postoperative). |
| Cumulative used amount and ratio of antiemetics | Cumulative used amount and ratio of antiemetics within 0-24 h after the first postoperative administration in each group | Frome administration until 24 hours after administration |