A Clinical Trial of YH14642 in Patients With Chronic Periodontal Disease

Chronic Periodontitis Clinical Trial

— YH14642  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499225
• Other study ID #: YH14642-201
• Status: Completed
• Phase: Phase 2
• First received: December 13, 2011
• Last updated: July 30, 2014
• Start date: December 2011

Study information

• Verified date: July 2014
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the efficacy and the safety of YH14642 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Subjects must be 20 years of age or older

• Have at least 18 natural teeth

• Four or more clinical attachment level(CAL) = 3mm

• Four or more periodontal pockets with a probing depth (PD) = 4mm

• Have Bleeding on probing

• Provide informed consent and willingness to cooperate with the study protocol

Exclusion Criteria:

• Forbidden History of Panax Notoginseng and Rehmanniae Radix Preparata

• Hypersensitivity of Doxycycline

• Hypersensitivity of Zea mays L. extract

• Critical diseases such as HIV previous three years

• Patients with mental retardation and dementia

• Systemic diseases such as diabetes and hypertension

• Patients who take Anticoagulants or Antiplatelet Agents

• Patients who have malignant tumor

• Smoker

• Continually use for 2weeks of phenytoin, calcium channel blocker, cyclosporin, coumarin, nonsteroidal anti-inflammatory drugs and aspirin use in the previous one month

• Patients who need malignant tumor

• Patients who received periodontal treatment within the last 6 months

• Pregnant or lactating females

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Gingival Diseases
• Periodontal Diseases
• Periodontitis

Intervention

Drug:
• YH14642 500mg Tab
YH14642 500mg per day(once a day)
• YH14642 500mg Tab
YH14642 1000mg per day(twice a day)
• YH14642 500mg Tab
YH14642 2000mg per day(three times a day)
• INSADOL[Zea mays L. extract] 35mg Tab
[Initiation dose : 4weeks after administraion] INSADOL[Zea mays L. extract] 210mg TAB per day [Maintain dose : Between 4weeks and 8weeks after administraion] INSADOL[Zea mays L. extract] 105mg TAB per day [Maintain dose : Between 8weeks and 12weeks after administraion] INSADOL[Zea mays L. extract] 105mg TAB per day
• DENTISTA[Doxycycline hyclate] 20mg Cap
DENTISTA[Doxycycline hyclate] Cap 40mg per day
• Placebo
Placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Dental Hospital	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, 8weeks and 12weeks	No
Secondary	Change in Clinical attachment level (CAL)		baseline, 4weeks, 8weeks and 12weeks	No
Secondary	Change in Bleeding on probing(BOP)		baseline, 4weeks, 8weeks and 12weeks	No
Secondary	change in Gingival index(GI)		baseline, 4weeks, 8weeks and 12weeks	No
Secondary	Change in Plaque index (PI)		baseline, 4weeks, 8weeks and 12weeks	No
Secondary	Change in Gingival recession(GR)		baseline, 4weeks, 8weeks and 12weeks	No
Secondary	[Exploratory Outcome Measure] Change in Alveolar bone height(ABH)		baseline and 12weeks	No
Secondary	[Exploratory Outcome Measure] Change in Alveolar bone density(ABD)		baseline and 12weeks	No