A Study to Evaluate the Efficacy and Safety of HR18042 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery.

A Multicenter, Randomized, Double-blind, Dose Finding, Parallel Controlled With Active Drug and Placebo, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR18042 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery

This is a multicenter, randomized, double-blind, dose finding, parallel controlled with active drug and placebo, phase II clinical trial, and the purpose of the study is to evaluate the efficacy and safety of HR18042 tablets for postoperative analgesia after impacted teeth removal surgery.

Study Overview

• Status: Terminated
• Conditions: Pain
• Intervention / Treatment: Drug: HR18042 tablets; Drug: HR18042 tablets; Drug: HR18042 tablets; Drug: Tramadol hydrochloride SR Tablets; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Stomatology Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years old.
2. Scheduled to remove the impacted tooth.
3. Any NRS score reaches the inclusion criteria 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 have used other drugs that have the analgesic effect.
2. Subjects who have used any drug that affect the efficacy and safety of study drug.
3. Subjects who have infection or other complications on the planned oral surgical site.
4. Subjects with hypertension or hypotension during screening period.
5. Subjects with severe cardiovascular and cerebrovascular diseases.
6. Subjects with severe gastrointestinal disease.
7. Subjects with Respiratory diseases.
8. Subjects with a history of seizure, or drug or alcohol abuse.
9. Subjects with significant abnormal electrocardiogram result.
10. Subjects with significant abnormal laboratory value.
11. Subject who were allergic to the study drug and ingredients.
12. Pregnancy, lactation or having recent pregnant plan.
13. Subjects who participated in other clinical research study 30 days before entering this study.
14. Other conditions unsuitable for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental A: HR18042 175mg	Drug: HR18042 tablets; Drug: HR 18042 tablets 175mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral; Drug: HR18042 tablets; Drug: HR 18042 tablets 225mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral; Drug: HR18042 tablets; Drug: HR 18042 tablets 275mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral
Experimental: Experimental B: HR18042 225mg	Drug: HR18042 tablets; Drug: HR 18042 tablets 175mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral; Drug: HR18042 tablets; Drug: HR 18042 tablets 225mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral; Drug: HR18042 tablets; Drug: HR 18042 tablets 275mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral
Experimental: Experimental C: HR18042 275mg	Drug: HR18042 tablets; Drug: HR 18042 tablets 175mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral; Drug: HR18042 tablets; Drug: HR 18042 tablets 225mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral; Drug: HR18042 tablets; Drug: HR 18042 tablets 275mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral
Active Comparator: Active Drug Comparator：Tramadol hydrochloride SR Tablets 100mg	Drug: Tramadol hydrochloride SR Tablets; Drug: Tramadol hydrochloride SR Tablets 100mg and placebos match to HR18042 tablets Dosing frequency: single dose; Route of administration: oral
Placebo Comparator: Placebo Comparator: Placebos match to HR18042 and Tramadol hydrochloride SR Tablets	Drug: Placebos; Drug: Placebos match to HR18042 tablets and Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome 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) within 4 hours after drug administration	0-4 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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
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) within 6 hours, 8 hours and 12 hours after drug administration	0 - 6 hours, 8 hours and 12 hours after drug administration
the Differences of Pain Intensity (PID) from 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
Sum of pain relief degree using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) within 4 hours, 6 hours, 8 hours, 12 hours after drug administration (SPAR)	0 - 4 hours, 6 hours, 8 hours and 12 hours after drug administration
Proportion of subjects who reach 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
Proportion of subjects who receive rescue therapy during the treatment period	0-12 hours after drug administration]

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2022
• Primary Completion (Actual): December 16, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Tramadol
• Other Study ID Numbers: HR18042-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No