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

NCT05470075 | Terminated Phase 2

• 1 other identifier: HR18042-202
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• 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 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

Study Arms (5)

Experimental A: HR18042 175mg

EXPERIMENTAL

Drug: HR18042 tablets

Experimental B: HR18042 225mg

EXPERIMENTAL

Drug: HR18042 tablets

Experimental C: HR18042 275mg

EXPERIMENTAL

Drug: HR18042 tablets

Active Drug Comparator：Tramadol hydrochloride SR Tablets 100mg

ACTIVE COMPARATOR

Drug: Tramadol hydrochloride SR Tablets

Placebo Comparator: Placebos match to HR18042 and Tramadol hydrochloride SR Tablets

PLACEBO COMPARATOR

Drug: Placebos

Interventions

HR18042 tablets DRUG

Drug: HR 18042 tablets 175mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral

Experimental A: HR18042 175mg

Tramadol hydrochloride SR Tablets DRUG

Drug: Tramadol hydrochloride SR Tablets 100mg and placebos match to HR18042 tablets Dosing frequency: single dose; Route of administration: oral

Active Drug Comparator：Tramadol hydrochloride SR Tablets 100mg

Placebos DRUG

Drug: Placebos match to HR18042 tablets and Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral

Placebo Comparator: Placebos match to HR18042 and Tramadol hydrochloride SR Tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old.
• Scheduled to remove the impacted tooth.
• Willing to comply with the study procedures and requirements.
• Willing and able to provide written informed consent for this study.

You may not qualify if:

• Subjects who have used other drugs that have the analgesic effect.
• Subjects who have used any drug that affect the efficacy and safety of study drug.
• Subjects who have infection or other complications on the planned oral surgical site.
• Subjects with hypertension or hypotension during screening period.
• Subjects with severe cardiovascular and cerebrovascular diseases.
• Subjects with severe gastrointestinal disease.
• Subjects with Respiratory diseases.
• Subjects with a history of seizure, or drug or alcohol abuse.
• Subjects with significant abnormal electrocardiogram result.
• Subjects with significant abnormal laboratory value.
• Subject who were allergic to the study drug and ingredients.
• Pregnancy, lactation or having recent pregnant plan.
• Subjects who participated in other clinical research study 30 days before entering this study.
• Other conditions unsuitable for participation in the study.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

West China Hospital of Stomatology Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized, double-blind, dose finding, parallel controlled with active drug and placebo, phase II clinical trial

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 22, 2022
• Study Start: August 11, 2022
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

CN (1)