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A Phase II Clinical Trial of YH23537 in Patients With Chronic Periodontal Disease.

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ClinicalTrials.gov Identifier: NCT02585596
Recruitment Status : Completed
First Posted : October 23, 2015
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

Brief Summary:
This study is designed to evaluate the efficacy and the safety of YH23537 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: YH23537 1000mg/day Drug: YH23537 2000mg/day Drug: YH23537 3000mg/day Drug: placebo Phase 2

Detailed Description:
at screening visit, at least existing 18 teeth,Mild/moderate/severe periodontitis patients diagnosed with chronic periodontitis according to the CDC / AAP (Center for Disease Control / American Academy for Periodontology) periodontitis classification (2012).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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 YH23537 Following 12-week Oral Administration in Patients With Chronic Periodontal Disease
Actual Study Start Date : December 16, 2015
Actual Primary Completion Date : December 28, 2016
Actual Study Completion Date : June 27, 2017

Arm Intervention/treatment
Experimental: YH23537 1000mg/day
YH23537 500mg 1 tab, placebo 500mg 2tab twice a day (before morning,evening meal) during 12 weeks
Drug: YH23537 1000mg/day
YH23537 500mg 2 tab

Drug: placebo
YH23537 500mg tab placebo

Experimental: YH23537 2000mg/day
YH23537 500mg 2tab, placebo 500mg 1tab twice day (before morning,evening meal) during 12 weeks
Drug: YH23537 2000mg/day
YH23537 500mg 4 tab

Drug: placebo
YH23537 500mg tab placebo

Experimental: YH23537 3000mg/day
YH23537 500mg 3tab a day twice day (before morning,evening meal) during 12 weeks
Drug: YH23537 3000mg/day
YH23537 500mg 6 tab

Experimental: YH23537 3000mg/day loading 1000mg/day
YH23537 500mg 3tab twice a day (before morning,evening meal) during 4weeks and YH23537 500mg tab twice a day (before morning,evening meal) during 8weeks
Drug: YH23537 1000mg/day
YH23537 500mg 2 tab

Drug: YH23537 3000mg/day
YH23537 500mg 6 tab

Drug: placebo
YH23537 500mg tab placebo

Placebo Comparator: Placebo
YH23537 500mg placebo 3tab twice a day
Drug: placebo
YH23537 500mg tab placebo




Primary Outcome Measures :
  1. Change in probing pocket depth (PD) [ Time Frame: baseline, 4weeks, 8week, 12weeks ]

Secondary Outcome Measures :
  1. Change in Clinical attachment level (CAL) [ Time Frame: baseline, 4weeks, 8week, 12weeks ]
  2. Change in Bleeding on probing(BOP) [ Time Frame: baseline, 4weeks, 8week, 12weeks ]
  3. Change in Gingival recession(GR) [ Time Frame: baseline, 4weeks, 8week, 12weeks ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be 19 years of age or older
  • Have at least 18 natural teeth
  • have been diagnosed with chronic periodontitis
  • have been diagnosed Mild/Moderate/Severe periodontitis with according to CDC / AAP periodontal classification (2012))
  • Provide informed consent and willingness to cooperate with the study protocol

Exclusion Criteria:

  • Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 4 weeks after the last dose of investigational product.
  • Pregnant or lactating females
  • Systemic diseases such as diabetes and hypertension
  • Patients who take Anticoagulants or Antiplatelet Agents
  • Continually use for phenytoin, calcium channel blocker, cyclosporin, coumarin, nonsteroidal anti-inflammatory drugs and aspirin use in the previous one month
  • Patients who received periodontal treatment within the last 6 months
  • Patients who have malignant tumor
  • History of positive serologic evidence of current infectious liver disease including HbsAg, or anti-HCV.
  • Patients with mental retardation and dementia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585596


Locations
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Korea, Republic of
Incheol Rhyu
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
Investigators
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Study Chair: Incheol Rhyu, Ph.D. Seoul National University Hospital

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Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT02585596     History of Changes
Other Study ID Numbers: YH23537-201
First Posted: October 23, 2015    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases