A Clinical Trial of YH14642 in Patients With Chronic Periodontal Disease (YH14642)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: Placebo; Drug: YH14642 500mg Tab; Drug: YH14642 500mg Tab; Drug: YH14642 500mg Tab; Drug: INSADOL[Zea mays L. extract] 35mg Tab; Drug: DENTISTA[Doxycycline hyclate] 20mg Cap

• Study Type: Interventional
• Enrollment (Anticipated): 162
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Dental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: YH14642 A-I	Drug: YH14642 500mg Tab; YH14642 500mg per day(once a day); Drug: YH14642 500mg Tab; YH14642 1000mg per day(twice a day); Drug: YH14642 500mg Tab; YH14642 2000mg per day(three times a day)
Experimental: YH14642 A-II	Drug: YH14642 500mg Tab; YH14642 500mg per day(once a day); Drug: YH14642 500mg Tab; YH14642 1000mg per day(twice a day); Drug: YH14642 500mg Tab; YH14642 2000mg per day(three times a day)
Experimental: YH14642 A-III	Drug: YH14642 500mg Tab; YH14642 500mg per day(once a day); Drug: YH14642 500mg Tab; YH14642 1000mg per day(twice a day); Drug: YH14642 500mg Tab; YH14642 2000mg per day(three times a day)
Active Comparator: Active Comparator B	Drug: 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
Active Comparator: Active Comparator C	Drug: DENTISTA[Doxycycline hyclate] 20mg Cap; DENTISTA[Doxycycline hyclate] Cap 40mg per day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Clinical attachment level (CAL)	baseline, 4weeks, 8weeks and 12weeks
Change in Bleeding on probing(BOP)	baseline, 4weeks, 8weeks and 12weeks
change in Gingival index(GI)	baseline, 4weeks, 8weeks and 12weeks
Change in Plaque index (PI)	baseline, 4weeks, 8weeks and 12weeks
Change in Gingival recession(GR)	baseline, 4weeks, 8weeks and 12weeks
[Exploratory Outcome Measure] Change in Alveolar bone height(ABH)	baseline and 12weeks
[Exploratory Outcome Measure] Change in Alveolar bone density(ABD)	baseline and 12weeks

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Publications and helpful links

General Publications

• Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: December 13, 2011
• First Submitted That Met QC Criteria: December 21, 2011
• First Posted (Estimate): December 26, 2011

Study Record Updates

• Last Update Posted (Estimate): July 31, 2014
• Last Update Submitted That Met QC Criteria: July 30, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases; Chronic Periodontitis; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: YH14642-201