NCT01499225

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

1.6 years

First QC Date

December 13, 2011

Last Update Submit

July 30, 2014

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Change in probing pocket depth (PD)

    baseline, 4weeks, 8weeks and 12weeks

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (6)

YH14642 A-I

EXPERIMENTAL
Drug: YH14642 500mg Tab

YH14642 A-II

EXPERIMENTAL
Drug: YH14642 500mg Tab

YH14642 A-III

EXPERIMENTAL
Drug: YH14642 500mg Tab

Active Comparator B

ACTIVE COMPARATOR
Drug: INSADOL[Zea mays L. extract] 35mg Tab

Active Comparator C

ACTIVE COMPARATOR
Drug: DENTISTA[Doxycycline hyclate] 20mg Cap

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

YH14642 500mg TabDRUG

YH14642 500mg per day(once a day)

YH14642 A-I
INSADOL[Zea mays L. extract] 35mg TabDRUG

\[Initiation dose : 4weeks after administraion\] 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 B
DENTISTA[Doxycycline hyclate] 20mg CapDRUG

DENTISTA\[Doxycycline hyclate\] Cap 40mg per day

Active Comparator C
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Dental Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33197289DERIVED

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Capsules

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2011

First Posted

December 26, 2011

Study Start

December 1, 2011

Primary Completion

July 1, 2013

Last Updated

July 31, 2014

Record last verified: 2014-07

Locations

KR(1)