A Study to Evaluate the Efficacy and Safety of HR18042 Tablets in the Treatment of Postoperative … (NCT04812860) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy and Safety of HR18042 Tablets in the Treatment of Postoperative Pain of Impacted Tooth.
China187 participantsStarted 2020-12-08
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 18 to 75 years old.
✓. Subjects must have a plan of extraction of impacted tooth.
✓. Subjects with moderate to severe pain (VAS score ≥ 50mm).This must be measured within a maximum of 4 hours after the end of extraction of impacted tooth.
✓. weight at least 45kg,and no more than 100kg.
✓. If a female is of child-bearing potential, she must be using highly effective methods of contraception throughout the study.
✓. Willingness to comply with the study procedures and requirements.
✓. willing and able to provide written informed consent for this study.
Exclusion criteria
✕. any analgesic medication other than preoperative or intraoperative anaesthetic agents within 12h before taking trial medication medication
✕. a longacting NSAID within 4 days,or a shortacting NSAID within 1 days prior to dosing.
✕. any anti-depressive medication, selective serotonin reuptake inhibitors (SSRIs), diet pills et.al. with 30 days of study entry.
✕. Oral surgical site combined with infection.
✕. Severe cardiovascular and cerebrovascular diseases.