A Clinical Trial of YH14642 in Patients With Chronic Periodontal Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01499225
First received: December 13, 2011
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Chronic Periodontitis
Drug: YH14642 500mg Tab
Drug: INSADOL[Zea mays L. extract] 35mg Tab
Drug: DENTISTA[Doxycycline hyclate] 20mg Cap
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • Change in probing pocket depth (PD) [ Time Frame: baseline, 4weeks, 8weeks and 12weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Clinical attachment level (CAL) [ Time Frame: baseline, 4weeks, 8weeks and 12weeks ] [ Designated as safety issue: No ]
  • Change in Bleeding on probing(BOP) [ Time Frame: baseline, 4weeks, 8weeks and 12weeks ] [ Designated as safety issue: No ]
  • change in Gingival index(GI) [ Time Frame: baseline, 4weeks, 8weeks and 12weeks ] [ Designated as safety issue: No ]
  • Change in Plaque index (PI) [ Time Frame: baseline, 4weeks, 8weeks and 12weeks ] [ Designated as safety issue: No ]
  • Change in Gingival recession(GR) [ Time Frame: baseline, 4weeks, 8weeks and 12weeks ] [ Designated as safety issue: No ]
  • [Exploratory Outcome Measure] Change in Alveolar bone height(ABH) [ Time Frame: baseline and 12weeks ] [ Designated as safety issue: No ]
  • [Exploratory Outcome Measure] Change in Alveolar bone density(ABD) [ Time Frame: baseline and 12weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 162
Study Start Date: December 2011
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YH14642 A-I Drug: YH14642 500mg Tab
YH14642 500mg per day(once a day)
Experimental: YH14642 A-II Drug: YH14642 500mg Tab
YH14642 1000mg per day(twice a day)
Experimental: YH14642 A-III 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
Placebo Comparator: Placebo Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499225

Locations
Korea, Republic of
Seoul National University Dental Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
  More Information

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01499225     History of Changes
Other Study ID Numbers: YH14642-201
Study First Received: December 13, 2011
Last Updated: July 30, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Periodontitis
Periodontal Diseases
Periodontitis
Mouth Diseases
Stomatognathic Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014