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The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for Postoperative analgesia in orthopaedics. To explore the reasonable dosage of HRS-2129 for Postoperative analgesia in orthopaedics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group: low\middle\high-dose | Experimental | HRS-2129; HRS-2129 placebo |
|
| Treatment group:placebo | Experimental | HRS-2129 placebo |
|
| Treatment group: positive control | Active Comparator | Tramadol Hydrochloride SR Tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-2129 | Drug | HRS-2129 |
| |
| HRS-2129 placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety:Incidence and severity of AE/SAE | from ICF signing date to day 12 since last dose(14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| the Sum of Pain Intensity Differences in Pain Score Over 6hour、12hour、16hour、24hour、48hour、12hour-24hour、24hour-48hour under static and moving condition | 48hours | |
| The response rate of NRS scores under static and moving condition at 24hour and 48hour after the first dose of medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610072 | China |
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| Drug |
HRS-2129 placebo |
|
| Tramadol Hydrochloride SR Tablets | Drug | Tramadol Hydrochloride SR Tablets |
|
| 48hours |
| Participant ' satisfaction score for analgesia treatment | 48hours |
| Investigator satisfaction score for analgesia treatment | 48hours |
| Time of first use of remedial analgesic medication | 48hours |
| Cumulative use of remedial analgesics | 48hours |
| Cmax | 5 days |
| Tmax | 5 days |
| AUC0-12h | 5 days |