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The purpose of this study was to evaluate the Efficacy and safety of HR18042 tablets for the Treatment of Post-surgical Pain After extraction of impacted tooth, find the optimal dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR18042 100mg | Experimental |
| |
| HR18042 125mg | Experimental |
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| HR18042 200mg | Experimental |
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| Tramadol hydrochloride ER 100mg | Active Comparator |
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| Placebo to match HR18042 and Tramadol hydrochloride ER | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR18042 | Drug | Tablet, Dosing frequency: once daily, Route of administration: oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| the Sum of Pain Intensity Differences(SPID) | SPID is derived as the weighted Sum of Pain Intensity Differences (baseline pain - current pain), measured at different time points via the PI-VAS. Time between two consecutive measurements will be used for weighting. Larger values indicate larger pain relief. | 0-8hours |
| Measure | Description | Time Frame |
|---|---|---|
| the Sum of Pain Intensity Differences(SPID) | 0-4hours | |
| the Sum of Pain Intensity Differences(SPID) | 0-12hours | |
| Pain Intensity Differences(PID) |
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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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A Multicenter,randomized, double-blind, Dose Ranging , controlled with active treatment and placebo, parallel groups, Phase II clinical trial
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| HR18042 |
| Drug |
Tablet,Dosing frequency: once daily, Route of administration: oral |
|
| HR18042 | Drug | Tablet,Dosing frequency: once daily, Route of administration: oral |
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| Tramadol hydrochloride ER | Drug | Tablet,Dosing frequency: once daily, Route of administration: oral |
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| Placebo | Drug | Tablet,Dosing frequency: once daily, Route of administration: oral |
|
Include pain intensity differences(PIDs) from baseline at each time point. measured at different time points via the PI-VAS. |
| 0-12hours |
| Pain relief(PAR) | pain relief (PAR) on a 5-point Likert scale (0, none, 1, a little, 2, some,3, a lot, 4, complete). | 0-12hours |
| the Sum of Pain relief Differences(SPAR) | SPAR is derived as the weighted Sum of Pain relief, measured at different time points via the 5-point Likert scale. Time between two consecutive measurements will be used for weighting. Larger values indicate larger pain relief. | 0-4hours |
| the Sum of Pain relief Differences(SPAR) | 0-8hours |
| the Sum of Pain relief Differences(SPAR). | 0-12hours |
| Subject who reaches a 30% reduction in pain intensity from baseline | 4hours、8hours、12hours |
| Subject who reaches a 50% reduction in pain intensity from baseline | 4hours、8hours、12hours |
| time to perceptible pain relief | 0-12hours |
| time to meaningful pain relief | Patients used one stopwatch to record the time to 'perceptible' PAR and another stopwatch for the time to'meaningful' PAR.Patients started timing upon intake of study medication and stopped one stopwatch at the onset of perceptible PAR and another upon achieving meaningful PAR. | 0-12hours |
| Time to first use of rescue medication | 0-12hours |
| Proportion of subjects who take of at least 1 dose of rescue medication | 0-12hours |
| Subject's overall assessment of study medication | Patients made an overall assessment of the study medication using a verbal rating scale (excellent, verygood, good, fair, poor). | 12hours |