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

Primary Purpose

Chronic Periodontitis

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

YH23537 1000mg/day

YH23537 2000mg/day

YH23537 3000mg/day

placebo

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Incheol Rhyu

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

YH23537 1000mg/day

YH23537 2000mg/day

YH23537 3000mg/day

YH23537 3000mg/day loading 1000mg/day

Placebo

Arm Description

YH23537 500mg 1 tab, placebo 500mg 2tab twice a day (before morning,evening meal) during 12 weeks

YH23537 500mg 2tab, placebo 500mg 1tab twice day (before morning,evening meal) during 12 weeks

YH23537 500mg 3tab a day twice day (before morning,evening meal) during 12 weeks

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

YH23537 500mg placebo 3tab twice a day

Outcomes

Primary Outcome Measures

Change in probing pocket depth (PD)

Secondary Outcome Measures

Change in Clinical attachment level (CAL)

Change in Bleeding on probing(BOP)

Change in Gingival recession(GR)

Full Information

NCT ID

NCT02585596

First Posted

October 21, 2015

Last Updated

January 14, 2019

Sponsor

Yuhan Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02585596

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

December 16, 2015 (Actual)

Primary Completion Date

December 28, 2016 (Actual)

Study Completion Date

June 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yuhan Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Periodontitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

275 (Actual)

8. Arms, Groups, and Interventions

Arm Title

YH23537 1000mg/day

Arm Type

Experimental

Arm Description

YH23537 500mg 1 tab, placebo 500mg 2tab twice a day (before morning,evening meal) during 12 weeks

Arm Title

YH23537 2000mg/day

Arm Type

Experimental

Arm Description

YH23537 500mg 2tab, placebo 500mg 1tab twice day (before morning,evening meal) during 12 weeks

Arm Title

YH23537 3000mg/day

Arm Type

Experimental

Arm Description

YH23537 500mg 3tab a day twice day (before morning,evening meal) during 12 weeks

Arm Title

YH23537 3000mg/day loading 1000mg/day

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

YH23537 500mg placebo 3tab twice a day

Intervention Type

Drug

Intervention Name(s)

YH23537 1000mg/day

Intervention Description

YH23537 500mg 2 tab

Intervention Type

Drug

Intervention Name(s)

YH23537 2000mg/day

Intervention Description

YH23537 500mg 4 tab

Intervention Type

Drug

Intervention Name(s)

YH23537 3000mg/day

Intervention Description

YH23537 500mg 6 tab

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

YH23537 500mg tab placebo

Primary Outcome Measure Information:

Title

Change in probing pocket depth (PD)

Time Frame

baseline, 4weeks, 8week, 12weeks

Secondary Outcome Measure Information:

Title

Change in Clinical attachment level (CAL)

Time Frame

baseline, 4weeks, 8week, 12weeks

Title

Change in Bleeding on probing(BOP)

Time Frame

baseline, 4weeks, 8week, 12weeks

Title

Change in Gingival recession(GR)

Time Frame

baseline, 4weeks, 8week, 12weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Incheol Rhyu, Ph.D.

Organizational Affiliation

Seoul National University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Incheol Rhyu

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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