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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

December 13, 2011
July 30, 2014
December 2011
July 2013   (final data collection date for primary outcome measure)
Change in probing pocket depth (PD) [ Time Frame: baseline, 4weeks, 8weeks and 12weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01499225 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Clinical Trial of YH14642 in Patients With Chronic Periodontal Disease
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Periodontitis
  • 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)
  • 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

  • Drug: DENTISTA[Doxycycline hyclate] 20mg Cap
    DENTISTA[Doxycycline hyclate] Cap 40mg per day
  • Drug: Placebo
    Placebo
  • Experimental: YH14642 A-I
    Intervention: Drug: YH14642 500mg Tab
  • Experimental: YH14642 A-II
    Intervention: Drug: YH14642 500mg Tab
  • Experimental: YH14642 A-III
    Intervention: Drug: YH14642 500mg Tab
  • Active Comparator: Active Comparator B
    Intervention: Drug: INSADOL[Zea mays L. extract] 35mg Tab
  • Active Comparator: Active Comparator C
    Intervention: Drug: DENTISTA[Doxycycline hyclate] 20mg Cap
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
Not Provided
July 2013   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01499225
YH14642-201
No
Yuhan Corporation
Yuhan Corporation
Not Provided
Not Provided
Yuhan Corporation
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP