Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of HR18042 Tablets in the Treatment of Postoperative Pain of Impacted Tooth.
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Moderate to Severe Acute Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
- Severe gastrointestinal disease.
- had a history of seizures or drug or alcohol abuse.
- uncontrolled hypertension.
- significant abnormal electrocardiogram
- significant abnormal laboratory value.
- Allergic to the study drug and ingredients.
- Pregnancy, lactation or recent Pregnant plan;
- Subjects who participated in a clinical research study involving an experimental drug before 30 days of study entry.
- other conditions unsuitable for participation in the study.
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2021
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT04812860
Start Date
December 8 2020
End Date
January 25 2021
Last Update
June 22 2025
Active Locations (1)
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1
West China Hospital of Stomatology Sichuan University
Chengdu, Sichuan, China, 610041