Pain
Conditions
Brief summary
The study is being conducted to evaluate the efficacy and safety of HRS4800 tablets for postoperative analgesia after impacted teeth removal surgery.
Interventions
DRUGHRS4800 tablets
Dosing frequency: single dose; Route of administration: oral
DRUGPlacebo tablets
Dosing frequency: single dose; Route of administration: oral
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A multicenter, randomized, double-blind, placebo-controlled, phase IIa clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 65 years old. 2. Scheduled to remove the impacted tooth. 3. Any NRS score ≥5 within 4 hours after the surgery. 4. Willing to comply with the study procedures and requirements. 5. Willing and able to provide written informed consent for this study.
Exclusion criteria
1. Subjects who had used other drugs that affect the analgesic effect. 2. Subjects who have infection or other complications on the planned oral surgical site. 3. Subjects with uncontrolled hypertension or hypotension. 4. Subjects with severe cardiovascular and cerebrovascular diseases. 5. Subjects with severe gastrointestinal disease. 6. Subjects with a history of drug or alcohol abuse. 7. Subjects with significant abnormal electrocardiogram. 8. Subjects with significant abnormal laboratory value. 9. Subject who were allergic to the study drug and ingredients. 10. Pregnancy, lactation or having recent pregnant plan. 11. Subjects who participated in other clinical research study 30 days before entering this study. 12. Other conditions unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) 0-8 hours after drug administration | 0-8 hours after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) 0-4 hours after drug administration | 0-4 hours after drug administration |
| the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) 0-12 hours after drug administrationadministration | 0-12 hours after drug administration |
| Pain relief degree at each evaluating timepoint using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration | 0-12 hours after drug administration |
| Sum of pain relief degree within 4 hours using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration (SPAR) | 0-4 hours after drug administration |
| Sum of pain relief degree within 8 hours using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration (SPAR) | 0-8 hours after drug administration |
| the Differences of Pain Intensity (PID) form each evaluating timepoint to baseline using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) after drug administration | 0-12 hours after drug administration |
| Proportion of subjects who reaches a 50% reduction in pain intensity from baseline using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) at each evaluating timepoint | 0-12 hours after drug administration |
| Time from drug administration to the first NRS score≤3 | 0-12 hours after drug administration |
| Time from drug administration to the first use of rescue medication | 0-12 hours after drug administration |
| Proportion of subjects who receive rescue therapy during the treatment period | 0-12 hours after drug administration |
| Subject's overall satisfaction score of the study medication using subject satisfaction scale (ranging from 0-10, the larger the number, the higher the satisfaction) | 12 hours after drug administration |
| Sum of pain relief degree within 12 hours using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration (SPAR) | 0-12 hours after drug administration |
Countries
China
Outcome results
None listed