NCT04812860

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Moderate to Severe Acute Pain

Interventions

Type	Name	Description
DRUG	HR18042	Tablet, Dosing frequency: once daily, Route of administration: oral
DRUG	HR18042	Tablet,Dosing frequency: once daily, Route of administration: oral
DRUG	HR18042	Tablet,Dosing frequency: once daily, Route of administration: oral
DRUG	Tramadol hydrochloride ER	Tablet,Dosing frequency: once daily, Route of administration: oral
DRUG	Placebo	Tablet,Dosing frequency: once daily, Route of administration: oral

Timeline

• Start date: 2020-12-08
• Primary completion: 2021-01-25
• Completion: 2021-01-25
• First posted: 2021-03-24
• Last updated: 2025-06-22

Locations

1 site across 1 country: China