NCT05470075

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2022-08-11
• Primary completion: 2022-12-16
• Completion: 2022-12-16
• First posted: 2022-07-22
• Last updated: 2025-06-26

Locations

1 site across 1 country: China