NCT01499225

A Clinical Trial of YH14642 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 YH14642 Following 12-week Oral Administration in Patients With Chronic Periodontal Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy and the safety of YH14642 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.

Conditions

• Chronic Periodontitis

Interventions

Type	Name	Description
DRUG	YH14642 500mg Tab	YH14642 500mg per day(once a day)
DRUG	YH14642 500mg Tab	YH14642 1000mg per day(twice a day)
DRUG	YH14642 500mg Tab	YH14642 2000mg per day(three times a day)
DRUG	INSADOL[Zea mays L. extract] 35mg Tab	\[Initiation dose : 4weeks after administraion\] INSADOL\[Zea mays L. extract\] 210mg TAB per day \[Maintain dose : Between 4weeks and 8weeks after administraion\] INSADOL\[Zea mays L. extract\] 105mg TAB per day \[Maintain dose : Between 8weeks and 12weeks after administraion\] INSADOL\[Zea mays L. extract\] 105mg TAB per day
DRUG	DENTISTA[Doxycycline hyclate] 20mg Cap	DENTISTA\[Doxycycline hyclate\] Cap 40mg per day
DRUG	Placebo	Placebo

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-07-01
• First posted: 2011-12-26
• Last updated: 2014-07-31

Locations

1 site across 1 country: South Korea