NCT02585596

A Phase II Clinical Trial of YH23537 in Patients With Chronic Periodontal Disease.

A Double-blind, Randomized, Parallel, Placebo-active Controlled, Multi-center Phase II Clinical Trial to Investigate the Efficacy and Safety of YH23537 Following 12-week Oral Administration in Patients With Chronic Periodontal Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy and the safety of YH23537 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.

Detailed description

at screening visit, at least existing 18 teeth,Mild/moderate/severe periodontitis patients diagnosed with chronic periodontitis according to the CDC / AAP (Center for Disease Control / American Academy for Periodontology) periodontitis classification (2012).

Conditions

• Chronic Periodontitis

Interventions

Type	Name	Description
DRUG	YH23537 1000mg/day	YH23537 500mg 2 tab
DRUG	YH23537 2000mg/day	YH23537 500mg 4 tab
DRUG	YH23537 3000mg/day	YH23537 500mg 6 tab
DRUG	placebo	YH23537 500mg tab placebo

Timeline

• Start date: 2015-12-16
• Primary completion: 2016-12-28
• Completion: 2017-06-27
• First posted: 2015-10-23
• Last updated: 2019-01-16

Locations

1 site across 1 country: South Korea