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This is a phase II/III, multi-center, randomized, double-blind, comparator-controlled study to evaluate the efficacy and safety of HRS-2129 for postoperative pain management in abdominal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-2129 low-dose group | Experimental |
| |
| HRS-2129 middle-dose group | Experimental |
| |
| HRS-2129 high-dose group | Experimental |
| |
| Blank preparation placebo group | Placebo Comparator |
| |
| Tramadol Hydrochloride SR Tablets group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-2129 Tablets | Drug | HRS-2129 tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| The time-weighted sum of differences in resting pain intensity within 48 hours after the start of administration of the investigational product. | Within 48 hours after the start of administration of the investigational product. |
| Measure | Description | Time Frame |
|---|---|---|
| The time-weighted sums of differences in resting pain intensity at 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration (Sum of Pain Intensity Difference, SPID). | At 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Tang | Contact | +86-0518-82342973 | lei.tang.lt31@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| Blank Preparation. | Drug | Blank preparation. |
|
| Tramadol Hydrochloride SR Tablets | Drug | Tramadol Hydrochloride SR tablets. |
|
| The time-weighted sums of differences in movement-related pain intensity at 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration. |
| At 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration. |
| Proportion of subjects with a reduction of ≥30%, ≥50%, and ≥70% in resting pain Numeric Rating Scales (NRS) scores from baseline at 24 hours and 48 hours after the first dose. | At 24 hours and 48 hours after the first dose. |
| Proportion of subjects with a reduction of ≥30%, ≥50%, and ≥70% in movement-related pain NRS scores from baseline at 24 hours and 48 hours after the first dose. | At 24 hours and 48 hours after the first dose. |
| Percentage of subjects who did not use rescue analgesics within 0-24 hours, 24-48 hours, and 0-48 hours after the first dose. | Within 0-24 hours, 24-48 hours, and 0-48 hours after the first dose. |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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