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

Phase 2TerminatedNCT05470075

Jiangsu HengRui Medicine Co., Ltd.110 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

110

Conditions

Pain

Interventions

HR18042 tabletsDRUG

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

HR18042 tabletsDRUG

Drug: HR 18042 tablets 225mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral

HR18042 tabletsDRUG

Drug: HR 18042 tablets 275mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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) within 4 hours after drug administration

Time frame: 0-4 hours after drug administration

Secondary 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) within 6 hours, 8 hours and 12 hours after drug administration

Time frame: 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

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 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)

Time frame: 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

Time frame: 0-12 hours after drug administration

Time from drug administration to the first NRS score≤3

Time frame: 0-12 hours after drug administration

Data from ClinicalTrials.gov

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