West China Hospital of Stomatology Sichuan University
Chengdu, Sichuan, 610041, China
NCT Number: NCT04812860
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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Notify Me18 year–75 year
All sexes
Interventional
Phase 2
Chengdu, Sichuan, 610041, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tablet, Dosing frequency: once daily, Route of administration: oral
Tablet,Dosing frequency: once daily, Route of administration: oral
Tablet,Dosing frequency: once daily, Route of administration: oral
Time frame: 0-8hours
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: 0-4hours
Time frame: 0-12hours
Time frame: 0-12hours
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) on a 5-point Likert scale (0, none, 1, a little, 2, some,3, a lot, 4, complete).
Time frame: 0-4hours
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: 0-8hours
Time frame: 0-12hours
Time frame: 4hours、8hours、12hours
Time frame: 4hours、8hours、12hours
Time frame: 0-12hours
Time frame: 0-12hours
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 frame: 0-12hours
Time frame: 12hours
Patients made an overall assessment of the study medication using a verbal rating scale (excellent, verygood, good, fair, poor).
Jiangsu HengRui Medicine Co., Ltd.
Industry
A Multicenter,Randomized, Double-blind, Dose Ranging , Active- and Placebo-controlled, Parallel Groups, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR18042 Tablets for the Treatment of Postoperative Pain of Impacted Tooth.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.