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

July 30, 2014 updated by: Yuhan Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in probing pocket depth (PD)
Time Frame: baseline, 4weeks, 8weeks and 12weeks
baseline, 4weeks, 8weeks and 12weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in Clinical attachment level (CAL)
Time Frame: baseline, 4weeks, 8weeks and 12weeks
baseline, 4weeks, 8weeks and 12weeks
Change in Bleeding on probing(BOP)
Time Frame: baseline, 4weeks, 8weeks and 12weeks
baseline, 4weeks, 8weeks and 12weeks
change in Gingival index(GI)
Time Frame: baseline, 4weeks, 8weeks and 12weeks
baseline, 4weeks, 8weeks and 12weeks
Change in Plaque index (PI)
Time Frame: baseline, 4weeks, 8weeks and 12weeks
baseline, 4weeks, 8weeks and 12weeks
Change in Gingival recession(GR)
Time Frame: baseline, 4weeks, 8weeks and 12weeks
baseline, 4weeks, 8weeks and 12weeks
[Exploratory Outcome Measure] Change in Alveolar bone height(ABH)
Time Frame: baseline and 12weeks
baseline and 12weeks
[Exploratory Outcome Measure] Change in Alveolar bone density(ABD)
Time Frame: baseline and 12weeks
baseline and 12weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuhan Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YH14642-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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