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The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after endoscopic surgery of the lower abdominal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR0410 Injection | Experimental |
| |
| Placebo for SHR0410 Injection | Placebo Comparator |
| |
| Morphine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0410 Injection | Drug | SHR0410 Injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the curve of pain intensity over 24 hours | Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity, administered over 24 hours. | 24-hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total consumption of remedial analgesics from 0h to 24h | Total consumption of IV morphine | 24-hours |
| Participant ' satisfaction score for analgesia treatment | Participants recalled the postoperative analgesia effect and rated their satisfaction on a scale of 0 to 10, with 0 representing dissatisfied and 10 representing very satisfied. |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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SHR0410 injection compared with placebo and morphine
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| Drug |
Placebo for SHR0410 Injection |
|
| Morphine | Drug | Morphine |
|
| 24-hours |
| Investigator satisfaction score for analgesia treatment | Postoperative analgesia was evaluated by investigators. The scale ranges from 0 to 10, with 0 being dissatisfied and 10 being very satisfied. | 24-hours |
| Frequency and severity of adverse events | Assessed by monitoring of adverse events. Participants with adverse events found to be related to the study drug will be compared to those receiving placebo or active comparator. | Day 4(or early termination on Day 3) |
| Safety as assessed by vital signs | Changes in vital signs such as body temperature, blood pressure, heart rate will be assessed at specified times. | Day 4(or early termination on Day 3) |
| Safety as assessed by laboratory evaluations | Assessed by laboratory evaluations at specified times. Participants with clinically significant lab values will be compared to those receiving placebo or active comparator. | Day 4(or early termination on Day 3) |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |