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The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with placebo and morphine in patients with acute postoperative pain following orthopedic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Experimental |
| |
| Treatment group C | Placebo Comparator |
| |
| Treatment group D | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR8554 | Drug | SHR8554 Injection; high dose |
| |
| SHR8554 |
| Measure | Description | Time Frame |
|---|---|---|
| the Sum of Pain Intensity Differences in Pain Score Over 48 Hours in the rest state | Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NPRS. | 48-hours |
| Measure | Description | Time Frame |
|---|---|---|
| the Sum of Pain Intensity Differences in Pain Score Over 6、12、48 、12-24、24-48 Hours under static condition | 48-hours | |
| the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under moving condition | 48-hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Cao, M.M | Contact | +0518-81220121 | caoyong@hrs.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Jiaotong University School of Medicine,Renji Hospital | Recruiting | Shanghai | Shanghai Municipality | 200127 | 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 |
|---|---|
| D000077330 | Saline Solution |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Parallel Assignment
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| Drug |
SHR8554 Injection; low dose |
|
| Saline Solution | Drug | Saline Solution |
|
| Morphine | Drug | Morphine |
|
| Time of first use of remedial analgesic medication | 48-hours |
| Cumulative use of remedial analgesics from 0h to 48h | 48-hours |
| Participant ' satisfaction score for analgesia treatment | 48-hours |
| Investigator satisfaction score for analgesia treatment | 48-hours |
| D009022 |
| Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| 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 |