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

Phase 2

• Conditions: Pain
• Interventions: Drug: HR18042 tablets; Drug: Tramadol hydrochloride SR Tablets; Drug: Placebos

• Registration Number: NCT05470075
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-22
• Study Start: 2022-08-11
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-08-31
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental C: HR18042 275mg	HR18042 tablets	-
Active Drug Comparator：Tramadol hydrochloride SR Tablets 100mg	Tramadol hydrochloride SR Tablets	-
Experimental A: HR18042 175mg	HR18042 tablets	-
Experimental B: HR18042 225mg	HR18042 tablets	-
Placebo Comparator: Placebos match to HR18042 and Tramadol hydrochloride SR Tablets	Placebos	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Proportion of subjects who receive rescue therapy during the treatment period	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
Time from drug administration to the first use of rescue medication	0-12 hours after drug administration
Time from drug administration to the first NRS score≤3	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
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

Trial Locations

Locations (1)

West China Hospital of Stomatology Sichuan University; 🇨🇳 Chengdu, Sichuan, China