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.

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.

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Acute Pain
• Intervention / Treatment: Drug: HR18042; Drug: HR18042; Drug: Tramadol hydrochloride ER; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 187
• 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 to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.
11. Allergic to the study drug and ingredients.
12. Pregnancy, lactation or recent Pregnant plan;
13. Subjects who participated in a clinical research study involving an experimental drug before 30 days of study entry.
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: HR18042 100mg	Drug: HR18042; Tablet, Dosing frequency: once daily, Route of administration: oral; Drug: HR18042; Tablet,Dosing frequency: once daily, Route of administration: oral
Experimental: HR18042 125mg	Drug: HR18042; Tablet, Dosing frequency: once daily, Route of administration: oral; Drug: HR18042; Tablet,Dosing frequency: once daily, Route of administration: oral
Experimental: HR18042 200mg	Drug: HR18042; Tablet, Dosing frequency: once daily, Route of administration: oral; Drug: HR18042; Tablet,Dosing frequency: once daily, Route of administration: oral
Active Comparator: Tramadol hydrochloride ER 100mg	Drug: Tramadol hydrochloride ER; Tablet,Dosing frequency: once daily, Route of administration: oral
Placebo Comparator: Placebo to match HR18042 and Tramadol hydrochloride ER	Drug: Placebo; Tablet,Dosing frequency: once daily, Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Sum of Pain Intensity Differences（SPID）	SPID is derived as the weighted Sum of Pain Intensity Differences (baseline pain - current pain), measured at different time points via the PI-VAS. Time between two consecutive measurements will be used for weighting. Larger values indicate larger pain relief.	0-8hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Sum of Pain Intensity Differences（SPID）		0-4hours
the Sum of Pain Intensity Differences（SPID）		0-12hours
Pain Intensity Differences（PID）	Include pain intensity differences(PIDs) from baseline at each time point. measured at different time points via the PI-VAS.	0-12hours
Pain relief（PAR）	pain relief (PAR) on a 5-point Likert scale (0, none, 1, a little, 2, some,3, a lot, 4, complete).	0-12hours
the Sum of Pain relief Differences（SPAR）	SPAR is derived as the weighted Sum of Pain relief, measured at different time points via the 5-point Likert scale. Time between two consecutive measurements will be used for weighting. Larger values indicate larger pain relief.	0-4hours
the Sum of Pain relief Differences（SPAR）		0-8hours
the Sum of Pain relief Differences（SPAR）.		0-12hours
Subject who reaches a 30% reduction in pain intensity from baseline		4hours、8hours、12hours
Subject who reaches a 50% reduction in pain intensity from baseline		4hours、8hours、12hours
time to perceptible pain relief		0-12hours
time to meaningful pain relief	Patients used one stopwatch to record the time to 'perceptible' PAR and another stopwatch for the time to'meaningful' PAR.Patients started timing upon intake of study medication and stopped one stopwatch at the onset of perceptible PAR and another upon achieving meaningful PAR.	0-12hours
Time to first use of rescue medication		0-12hours
Proportion of subjects who take of at least 1 dose of rescue medication		0-12hours
Subject's overall assessment of study medication	Patients made an overall assessment of the study medication using a verbal rating scale (excellent, verygood, good, fair, poor).	12hours

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2020
• Primary Completion (Actual): January 25, 2021
• Study Completion (Actual): January 25, 2021

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 20, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Acute Pain; 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: HR18042-201

Drug and device information, study documents

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