Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of HRS4800 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery.
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The study is being conducted to evaluate the efficacy and safety of HRS4800 tablets for postoperative analgesia after impacted teeth removal surgery.
Eligibility Criteria
Inclusion
- 18 to 65 years old.
- Scheduled to remove the impacted tooth.
- Any NRS score ≥5 within 4 hours after the surgery.
- Willing to comply with the study procedures and requirements.
- Willing and able to provide written informed consent for this study.
Exclusion
- Subjects who had used other drugs that affect the analgesic effect.
- Subjects who have infection or other complications on the planned oral surgical site.
- Subjects with uncontrolled hypertension or hypotension.
- Subjects with severe cardiovascular and cerebrovascular diseases.
- Subjects with severe gastrointestinal disease.
- Subjects with a history of drug or alcohol abuse.
- Subjects with significant abnormal electrocardiogram.
- Subjects with significant abnormal laboratory value.
- Subject who were allergic to the study drug and ingredients.
- Pregnancy, lactation or having recent pregnant plan.
- Subjects who participated in other clinical research study 30 days before entering this study.
- Other conditions unsuitable for participation in the study.
Key Trial Info
Start Date :
January 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2022
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05318846
Start Date
January 14 2022
End Date
March 22 2022
Last Update
April 8 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
West China Hospital of Stomatology Sichuan University
Chengdu, Sichuan, China, 610041