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

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0001093

Enrollment

162

Registered

2014-04-28

Start date

2012-01-31

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : ? Experimental group experimental group A - I: YH14642 500 mg/Day experimental group A -II: YH14642 1000 mg/Day experimental group A- III: YH14642 2000 mg/Day ? Active comparator group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy male and female aged above 20 2. who has chronic periodontal disease during screening 3. Provision of signed written informed consent

Exclusion criteria

Exclusion criteria: 1)Subject who is hypersensitive to drug 2)Suject who has history or presence of clinically significant diseas 3)Subject who stopped smoking within 1 months before the treatment or weren't able to stop smoking during the hospitalization 4)Medically unacceptable contraception used during the clinical trial 5)Subject who participated in another clinical trial within 1 months before enrolled in this study 6)Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.

Design outcomes

Primary

Measure	Time frame
change of Clinical attachment level	—

Secondary

Measure	Time frame
change of Clinical attachment level	—

Countries

Korea, Republic of

Contacts

Public ContactIn Kim

Seoul National University Dental Hospital

Outcome results