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

Primary Purpose

Chronic Periodontitis

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

YH14642 500mg Tab

INSADOL[Zea mays L. extract] 35mg Tab

DENTISTA[Doxycycline hyclate] 20mg Cap

Placebo

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

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

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

Sites / Locations

Seoul National University Dental Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

YH14642 A-I

YH14642 A-II

YH14642 A-III

Active Comparator B

Active Comparator C

Placebo

Arm Description

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 index(GI)

Change in Plaque index (PI)

Change in Gingival recession(GR)

[Exploratory Outcome Measure] Change in Alveolar bone height(ABH)

[Exploratory Outcome Measure] Change in Alveolar bone density(ABD)

Full Information

NCT ID

NCT01499225

First Posted

December 13, 2011

Last Updated

July 30, 2014

Sponsor

Yuhan Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01499225

Brief Title

A Clinical Trial of YH14642 in Patients With Chronic Periodontal Disease

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

undefined (undefined)

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 YH14642 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.

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

162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

YH14642 A-I

Arm Type

Experimental

Arm Title

YH14642 A-II

Arm Type

Experimental

Arm Title

YH14642 A-III

Arm Type

Experimental

Arm Title

Active Comparator B

Arm Type

Active Comparator

Arm Title

Active Comparator C

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

YH14642 500mg Tab

Intervention Description

YH14642 500mg per day(once a day)

Intervention Type

Drug

Intervention Name(s)

YH14642 500mg Tab

Intervention Description

YH14642 1000mg per day(twice a day)

Intervention Type

Drug

Intervention Name(s)

YH14642 500mg Tab

Intervention Description

YH14642 2000mg per day(three times a day)

Intervention Type

Drug

Intervention Name(s)

INSADOL[Zea mays L. extract] 35mg Tab

Intervention Description

[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

Intervention Type

Drug

Intervention Name(s)

DENTISTA[Doxycycline hyclate] 20mg Cap

Intervention Description

DENTISTA[Doxycycline hyclate] Cap 40mg per day

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change in probing pocket depth (PD)

Time Frame