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The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after laparoscopic surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | SHR0410 Injection(Low Dose) |
|
| Treatment group B | Experimental | SHR0410 Injection(High Dose) |
|
| Treatment group C | Placebo Comparator | Placebo for SHR0410 Injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0410 Injection | Drug | SHR0410 Injection(Low Dose) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Summed Pain Intensity Difference From 0-24 Hours (SPID0-24) | Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity. | 0 to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Summed Pain Intensity Difference Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours (SPID2、SPID4、SPID6、 SPID12、SPID18) | Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity. | 0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qin Liu | Contact | +0518-82342973 | qin.liu@hengrui.com |
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SHR0410 injection compared with placebo
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| SHR0410 Injection |
| Drug |
SHR0410 Injection(High Dose) |
|
| Placebo | Drug | Placebo for SHR0410 Injection. |
|
| Estimated Time From The Start Of The Infusion Of Study Drug To The First NRS reaching 3 or less |
| 0 to 24 hours |
| Total Pain Relief Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours、24 Hours | Patients reported their pain relief using a 5-point(0-4) categorical scale (PR), with "0" indicating "No Relief", "1" indicating "A Little Relief", "2" indicating "Some Relief ", "3" indicating "A Lot of Relief" and "4" indicating "Complete Relief". | 0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours、0 to 24 hours |
| Total consumption of remedial analgesics from 0 to 24 hours | 24-hours |
| Participant' Satisfaction Score For Analgesia Treatment | 24-hours |
| Investigator Satisfaction Score For Analgesia Treatment | 24-hours |
| Numbers of Participants With Abnormal Vital Signs | Changes in vital signs such as body temperature (using the celsius system) will be assessed at specified times. | Day 3 or Day 4 |
| Numbers of Participants With Abnormal Vital Signs | Changes in vital signs such as, blood pressure (using mmHg) will be assessed at specified times. | Day 3 or Day 4 |
| Numbers of Participants With Abnormal Vital Signs | Changes in vital signs such as , heart rate (measured by beats per minute) will be assessed at specified times. | Day 3 or Day 4 |
| Numbers of Participants With Abnormal Laboratory Values | Participants with clinically significant lab values will be compared to those receiving placebo comparator. | Day 3 or Day 4 |