A Clinical Trial of YH14642 in Patients With Chronic Periodontal Disease
NCT ID: NCT01499225
Last Updated: 2014-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
162 participants
INTERVENTIONAL
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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YH14642 A-I
YH14642 500mg Tab
YH14642 500mg per day(once a day)
YH14642 A-II
YH14642 500mg Tab
YH14642 1000mg per day(twice a day)
YH14642 A-III
YH14642 500mg Tab
YH14642 2000mg per day(three times a day)
Active Comparator B
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 C
DENTISTA[Doxycycline hyclate] 20mg Cap
DENTISTA\[Doxycycline hyclate\] Cap 40mg per day
Placebo
Placebo
Placebo
Interventions
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YH14642 500mg Tab
YH14642 500mg per day(once a day)
YH14642 500mg Tab
YH14642 1000mg per day(twice a day)
YH14642 500mg Tab
YH14642 2000mg per day(three times a day)
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
DENTISTA[Doxycycline hyclate] 20mg Cap
DENTISTA\[Doxycycline hyclate\] Cap 40mg per day
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Locations
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Seoul National University Dental Hospital
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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YH14642-201
Identifier Type: -
Identifier Source: org_study_id