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The study is being conducted to evaluate the efficacy and safety of HRS4800 tablets for postoperative analgesia after impacted teeth removal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS4800 tablets | Drug | Dosing frequency: single dose; Route of administration: oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) 0-8 hours after drug administration | 0-8 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| the Differences of Pain Intensity (PID) form each evaluating timepoint to baseline using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) after drug administration | 0-12 hours after drug administration | |
| the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) 0-4 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Stomatology 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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A multicenter, randomized, double-blind, placebo-controlled, phase IIa clinical trial
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| Placebo tablets |
| Drug |
Dosing frequency: single dose; Route of administration: oral |
|
| 0-4 hours after drug administration |
| the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) 0-12 hours after drug administrationadministration | 0-12 hours after drug administration |
| Pain relief degree at each evaluating timepoint using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration | 0-12 hours after drug administration |
| Sum of pain relief degree within 4 hours using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration (SPAR) | 0-4 hours after drug administration |
| Sum of pain relief degree within 8 hours using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration (SPAR) | 0-8 hours after drug administration |
| Sum of pain relief degree within 12 hours using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration (SPAR) | 0-12 hours after drug administration |
| Proportion of subjects who reaches a 50% reduction in pain intensity from baseline using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) at each evaluating timepoint | 0-12 hours after drug administration |
| Time from drug administration to the first NRS scoreā¤3 | 0-12 hours after drug administration |
| Time from drug administration to the first use of rescue medication | 0-12 hours after drug administration |
| Proportion of subjects who receive rescue therapy during the treatment period | 0-12 hours after drug administration |
| Subject's overall satisfaction score of the study medication using subject satisfaction scale (ranging from 0-10, the larger the number, the higher the satisfaction) | 12 hours after drug administration |