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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: YH23537 1000mg/day; Drug: placebo; Drug: YH23537 2000mg/day; Drug: YH23537 3000mg/day

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).

• Study Type: Interventional
• Enrollment (Actual): 275
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Incheol Rhyu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must be 19 years of age or older
• Have at least 18 natural teeth
• have been diagnosed with chronic periodontitis
• have been diagnosed Mild/Moderate/Severe periodontitis with according to CDC / AAP periodontal classification (2012))
• Provide informed consent and willingness to cooperate with the study protocol

Exclusion Criteria:

• Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 4 weeks after the last dose of investigational product.
• Pregnant or lactating females
• Systemic diseases such as diabetes and hypertension
• Patients who take Anticoagulants or Antiplatelet Agents
• Continually use for phenytoin, calcium channel blocker, cyclosporin, coumarin, nonsteroidal anti-inflammatory drugs and aspirin use in the previous one month
• Patients who received periodontal treatment within the last 6 months
• Patients who have malignant tumor
• History of positive serologic evidence of current infectious liver disease including HbsAg, or anti-HCV.
• Patients with mental retardation and dementia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YH23537 1000mg/day; YH23537 500mg 1 tab, placebo 500mg 2tab twice a day (before morning,evening meal) during 12 weeks	Drug: YH23537 1000mg/day; YH23537 500mg 2 tab; Drug: placebo; YH23537 500mg tab placebo
Experimental: YH23537 2000mg/day; YH23537 500mg 2tab, placebo 500mg 1tab twice day (before morning,evening meal) during 12 weeks	Drug: placebo; YH23537 500mg tab placebo; Drug: YH23537 2000mg/day; YH23537 500mg 4 tab
Experimental: YH23537 3000mg/day; YH23537 500mg 3tab a day twice day (before morning,evening meal) during 12 weeks	Drug: YH23537 3000mg/day; YH23537 500mg 6 tab
Experimental: YH23537 3000mg/day loading 1000mg/day; YH23537 500mg 3tab twice a day (before morning,evening meal) during 4weeks and YH23537 500mg tab twice a day (before morning,evening meal) during 8weeks	Drug: YH23537 1000mg/day; YH23537 500mg 2 tab; Drug: placebo; YH23537 500mg tab placebo; Drug: YH23537 3000mg/day; YH23537 500mg 6 tab
Placebo Comparator: Placebo; YH23537 500mg placebo 3tab twice a day	Drug: placebo; YH23537 500mg tab placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in probing pocket depth (PD)	baseline, 4weeks, 8week, 12weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Clinical attachment level (CAL)	baseline, 4weeks, 8week, 12weeks
Change in Bleeding on probing(BOP)	baseline, 4weeks, 8week, 12weeks
Change in Gingival recession(GR)	baseline, 4weeks, 8week, 12weeks

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Study Chair: Incheol Rhyu, Ph.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2015
• Primary Completion (Actual): December 28, 2016
• Study Completion (Actual): June 27, 2017

Study Registration Dates

• First Submitted: October 21, 2015
• First Submitted That Met QC Criteria: October 21, 2015
• First Posted (Estimate): October 23, 2015

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases; Chronic Periodontitis
• Other Study ID Numbers: YH23537-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO