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This is a multi-center, randomized, double-blind, placebo/active-controlled study. About 387 subjects undergoing elective abdominal operation under general anesthesia are planned to be enrolled and randomized into the HSK21542 group (129 subjects), tramadol group (129 subjects), and placebo group (129 subjects).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK21542 | Experimental | HSK21542 injection |
|
| tramadol | Experimental | Tramadol hydrochloride injection |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK21542 Injection | Drug | 1μg/kg/dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Differences (SPID) in the HSK21542 group and the placebo group | Time-weighted SPID at rest within 0-24 h after the first administration in the HSK21542 group and the placebo group | From administration until 24 hours after administration |
| Sum of Pain Intensity Differences (SPID) in tramadol group and the placebo group | Time-weighted SPID at rest within 0-24 h after the first administration in the tramadol group and the placebo group | From administration until 24 hours after administration |
| Sum of Pain Intensity Differences (SPID) in the HSK21542 group and the tramadol group | Time-weighted SPID at rest within 0-24 h after the first administration in the HSK21542 group and the tramadol group | From administration until 24 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Use of remedial analgesics within 0-12 h | Cumulative used amount of remedial analgesics within 0-12 h after the first administration, percentage of subjects not using remedial analgesics, and start time of remedial analgesic use | From administration until 12 hours after administration |
| Use of remedial analgesics within 0-24 h |
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Inclusion Criteria:
Exclusion Criteria:
Previous and concomitant diseases
1. Subjects with a history or evidence of any of the following diseases before screening:
Past and concomitant medications 2. Known allergies or contraindications to opiates and other drugs that might be used in the clinical trial such as anesthetics (propofol/sevoflurane), muscle relaxants (cisatracurium), antiemetics (tropisetron); 3. Receipt of any one of the following medications or treatments at screening(with the exception of drugs specified in the protocol):
Laboratory and other tests 4. The laboratory test parameters measured at screening reach one of the following criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong U | Wuhan | 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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| ID | Term |
|---|---|
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Tramadol hydrochloride | Drug | 50mg/dose |
|
|
| placebo | Drug | placebo |
|
Cumulative used amount of remedial analgesics within 0-24 h after the first administration, percentage of subjects not using remedial analgesics, and start time of remedial analgesic use |
| From administration until 24 hours after administration |
| Sum of Pain Intensity Differences (SPID) in each group | Time-weighted SPID at rest within 0-12 h after the first administration | From administration until 12 hours after administration |
| Pain intensity difference (PID) | The PID at rest at each scoring time point after the first administration | From administration until 24 hours after administration |
| Numerical rating scale(NRS)in each group | The NRS score at each scoring time point after the first administration | From administration until 24 hours after administration |
| Numerical rating scale(NRS)at 0-12 h | The ratio of subjects with NRS score ≤ 3 for resting pain at 0-12 h after the first administration | From administration until 12 hours after administration |
| Numerical rating scale(NRS)at 0-24 h | The ratio of subjects with NRS score ≤ 3 for resting pain at 0-24 h after the first administration | From administration until 24 hours after administration |
| Duration of analgesia after the first administration | duration of NRS score ≤ 3 within 24 h after the first postoperative administration or the sum of the duration of NRS score ≤ 3 with fluctuations in pain within 24 h | From 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 administration | From administration until 24 hours after administration |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |