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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
187
West China Hospital of Stomatology Sichuan University
Chengdu, Sichuan, China
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.
Time frame: 0-8hours
the Sum of Pain Intensity Differences(SPID)
Time frame: 0-4hours
the Sum of Pain Intensity Differences(SPID)
Time frame: 0-12hours
Pain Intensity Differences(PID)
Include pain intensity differences(PIDs) from baseline at each time point. measured at different time points via the PI-VAS.
Time frame: 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).
Time frame: 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.
Time frame: 0-4hours
the Sum of Pain relief Differences(SPAR)
Time frame: 0-8hours
the Sum of Pain relief Differences(SPAR).
Time frame: 0-12hours
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Tablet,Dosing frequency: once daily, Route of administration: oral
Tablet,Dosing frequency: once daily, Route of administration: oral
Subject who reaches a 30% reduction in pain intensity from baseline
Time frame: 4hours、8hours、12hours
Subject who reaches a 50% reduction in pain intensity from baseline
Time frame: 4hours、8hours、12hours
time to perceptible pain relief
Time frame: 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.
Time frame: 0-12hours
Time to first use of rescue medication
Time frame: 0-12hours
Proportion of subjects who take of at least 1 dose of rescue medication
Time frame: 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).
Time frame: 12hours