A Clinical Trial of YH14642 in Patients With Chronic Periodontal Disease

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: YH14642 500mg Tab; Drug: Placebo; Drug: INSADOL[Zea mays L. extract] 35mg Tab; Drug: DENTISTA[Doxycycline hyclate] 20mg Cap

• Registration Number: NCT01499225
• Lead Sponsor: Yuhan Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-26
• Primary Completion: 2013-07
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-30
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YH14642 A-II	YH14642 500mg Tab	-
Placebo	Placebo	-
YH14642 A-III	YH14642 500mg Tab	-
YH14642 A-I	YH14642 500mg Tab	-
Active Comparator B	INSADOL[Zea mays L. extract] 35mg Tab	-
Active Comparator C	DENTISTA[Doxycycline hyclate] 20mg Cap	-

Primary Outcome Measures

Name	Time	Method
Change in probing pocket depth (PD)	baseline, 4weeks, 8weeks and 12weeks

Secondary Outcome Measures

Name	Time	Method
Change in Clinical attachment level (CAL)	baseline, 4weeks, 8weeks and 12weeks
Change in Bleeding on probing(BOP)	baseline, 4weeks, 8weeks and 12weeks
change in Gingival index(GI)	baseline, 4weeks, 8weeks and 12weeks
[Exploratory Outcome Measure] Change in Alveolar bone density(ABD)	baseline and 12weeks
Change in Gingival recession(GR)	baseline, 4weeks, 8weeks and 12weeks
[Exploratory Outcome Measure] Change in Alveolar bone height(ABH)	baseline and 12weeks
Change in Plaque index (PI)	baseline, 4weeks, 8weeks and 12weeks

Trial Locations

Locations (1)

Seoul National University Dental Hospital; 🇰🇷 Seoul, Korea, Republic of