A Clinical Trial of YH14642 in Patients With Chronic Periodontal Disease

Yuhan

Status and phase: Completed; Phase 2

Conditions: Chronic Periodontitis

Treatments: Drug: DENTISTA[Doxycycline hyclate] 20mg Cap; Drug: INSADOL[Zea mays L. extract] 35mg Tab; Drug: Placebo; Drug: YH14642 500mg Tab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01499225

YH14642-201

Details and patient eligibility

About

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.

Enrollment: 162 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

162 participants in 6 patient groups, including a placebo group

YH14642 A-I

Experimental group

Treatment:

Drug: YH14642 500mg Tab

Drug: YH14642 500mg Tab

Drug: YH14642 500mg Tab

YH14642 A-II

Experimental group

Treatment:

Drug: YH14642 500mg Tab

Drug: YH14642 500mg Tab

Drug: YH14642 500mg Tab

YH14642 A-III

Experimental group

Treatment:

Drug: YH14642 500mg Tab

Drug: YH14642 500mg Tab

Drug: YH14642 500mg Tab

Active Comparator B

Active Comparator group

Treatment:

Drug: INSADOL[Zea mays L. extract] 35mg Tab

Active Comparator C

Active Comparator group

Treatment:

Drug: DENTISTA[Doxycycline hyclate] 20mg Cap

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo