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

Chronic Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585596
• Other study ID #: YH23537-201
• Status: Completed
• Phase: Phase 2
• Start date: December 16, 2015
• Est. completion date: June 27, 2017

Study information

• Verified date: January 2019
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: June 27, 2017
• Est. primary completion date: December 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontal Diseases
• Periodontitis

Intervention

Drug:
• YH23537 1000mg/day
YH23537 500mg 2 tab
• YH23537 2000mg/day
YH23537 500mg 4 tab
• YH23537 3000mg/day
YH23537 500mg 6 tab
• placebo
YH23537 500mg tab placebo

Locations

Country	Name	City	State
Korea, Republic of	Incheol Rhyu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in probing pocket depth (PD)		baseline, 4weeks, 8week, 12weeks
Secondary	Change in Clinical attachment level (CAL)		baseline, 4weeks, 8week, 12weeks
Secondary	Change in Bleeding on probing(BOP)		baseline, 4weeks, 8week, 12weeks
Secondary	Change in Gingival recession(GR)		baseline, 4weeks, 8week, 12weeks