NCT02585596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 16, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2017

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

October 21, 2015

Last Update Submit

January 14, 2019

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Change in probing pocket depth (PD)

    baseline, 4weeks, 8week, 12weeks

Secondary Outcomes (3)

  • 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

Study Arms (5)

YH23537 1000mg/day

EXPERIMENTAL

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

Drug: YH23537 1000mg/dayDrug: placebo

YH23537 2000mg/day

EXPERIMENTAL

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

Drug: YH23537 2000mg/dayDrug: placebo

YH23537 3000mg/day

EXPERIMENTAL

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

Drug: YH23537 3000mg/day

YH23537 3000mg/day loading 1000mg/day

EXPERIMENTAL

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/dayDrug: YH23537 3000mg/dayDrug: placebo

Placebo

PLACEBO COMPARATOR

YH23537 500mg placebo 3tab twice a day

Drug: placebo

Interventions

YH23537 1000mg/dayDRUG

YH23537 500mg 2 tab

YH23537 1000mg/dayYH23537 3000mg/day loading 1000mg/day
YH23537 2000mg/dayDRUG

YH23537 500mg 4 tab

YH23537 2000mg/day
YH23537 3000mg/dayDRUG

YH23537 500mg 6 tab

YH23537 3000mg/dayYH23537 3000mg/day loading 1000mg/day
placeboDRUG

YH23537 500mg tab placebo

PlaceboYH23537 1000mg/dayYH23537 2000mg/dayYH23537 3000mg/day loading 1000mg/day

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Incheol Rhyu

Seoul, South Korea

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Incheol Rhyu, Ph.D.

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2015

First Posted

October 23, 2015

Study Start

December 16, 2015

Primary Completion

December 28, 2016

Study Completion

June 27, 2017

Last Updated

January 16, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)