A Study to Evaluate the Efficacy and Safety of HR18042 Tablets in the Treatment of Postoperative Pain of Impacted Tooth.

A Multicenter,Randomized, Double-blind, Dose Ranging , Active- and Placebo-controlled, Parallel Groups, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR18042 Tablets for the Treatment of Postoperative Pain of Impacted Tooth.

NCT04812860•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18 to 75 years old.
•2. Subjects must have a plan of extraction of impacted tooth.
•3. 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.
•4. weight at least 45kg,and no more than 100kg.
•5. If a female is of child-bearing potential, she must be using highly effective methods of contraception throughout the study.
•6. Willingness to comply with the study procedures and requirements.
•7. willing and able to provide written informed consent for this study.

Exclusion Criteria

•1. any analgesic medication other than preoperative or intraoperative anaesthetic agents within 12h before taking trial medication medication
•2. a longacting NSAID within 4 days,or a shortacting NSAID within 1 days prior to dosing.
•3. any anti-depressive medication, selective serotonin reuptake inhibitors (SSRIs), diet pills et.al. with 30 days of study entry.
•4. Oral surgical site combined with infection.
•5. Severe cardiovascular and cerebrovascular diseases.
•6. Severe gastrointestinal disease.
•7. had a history of seizures or drug or alcohol abuse.
•8. uncontrolled hypertension.
•9. significant abnormal electrocardiogram
•10. significant abnormal laboratory value.
+4 more criteria

Locations (1)

West China Hospital of Stomatology Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

December 8, 2020

Primary Completion Date

January 25, 2021

Completion Date

January 25, 2021

Last Updated

June 22, 2025

Enrollment

187

ACTUAL participants

Conditions

Moderate to Severe Acute Pain

Interventions

HR18042

DRUG

HR18042

DRUG

HR18042

DRUG

Tramadol hydrochloride ER

DRUG

Placebo

DRUG