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Completed

NCT Number: NCT02585596

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

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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Incheol Rhyu

Seoul, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YH23537 1000mg/day

Drug

YH23537 500mg 2 tab

YH23537 2000mg/day

Drug

YH23537 500mg 4 tab

YH23537 3000mg/day

Drug

YH23537 500mg 6 tab

Placebo

Drug

YH23537 500mg tab placebo

Primary outcomes

  1. Change in probing pocket depth (PD)

    Time frame: baseline, 4weeks, 8week, 12weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Oct 23, 2015
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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