A Study to Evaluate the Efficacy and Safety of HRS4800 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery.

Jiangsu HengRui Medicine Co., Ltd.38 enrolled

Overview

The study is being conducted to evaluate the efficacy and safety of HRS4800 tablets for postoperative analgesia after impacted teeth removal surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain

Interventions

HRS4800 tabletsDRUG

Dosing frequency: single dose; Route of administration: oral

Placebo tabletsDRUG

Dosing frequency: single dose; Route of administration: oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

West China Hospital of Stomatology Sichuan University

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

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

Time frame: 0-8 hours after drug administration

Secondary Outcomes

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

Time frame: 0-12 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) 0-4 hours after drug administration

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 0-8 hours after drug administration

Data from ClinicalTrials.gov

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