A Clinical Trial of YH14642 in Patients With Chronic Periodontal Disease

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Yuhan Corporation

ClinicalTrials.gov Identifier:

NCT01499225

First received: December 13, 2011

Last updated: May 13, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	December 13, 2011
Last Updated Date	May 13, 2013
Start Date ^ICMJE	December 2011
Estimated Primary Completion Date	July 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 21, 2011)	Change in probing pocket depth (PD) [ Time Frame: baseline, 4weeks, 8weeks and 12weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01499225 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 21, 2011)	Change in Clinical attachment level (CAL) [ Time Frame: baseline, 4weeks, 8weeks and 12weeks ] [ Designated as safety issue: No ] Change in Bleeding on probing(BOP) [ Time Frame: baseline, 4weeks, 8weeks and 12weeks ] [ Designated as safety issue: No ] change in Gingival index(GI) [ Time Frame: baseline, 4weeks, 8weeks and 12weeks ] [ Designated as safety issue: No ] Change in Plaque index (PI) [ Time Frame: baseline, 4weeks, 8weeks and 12weeks ] [ Designated as safety issue: No ] Change in Gingival recession(GR) [ Time Frame: baseline, 4weeks, 8weeks and 12weeks ] [ Designated as safety issue: No ] [Exploratory Outcome Measure] Change in Alveolar bone height(ABH) [ Time Frame: baseline and 12weeks ] [ Designated as safety issue: No ] [Exploratory Outcome Measure] Change in Alveolar bone density(ABD) [ Time Frame: baseline and 12weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Clinical Trial of YH14642 in Patients With Chronic Periodontal Disease
Official Title ^ICMJE	A Double-blind, Randomized, Parallel, Placebo-active Controlled, Multi-center Phase II Clinical Trial to Investigate the Efficacy and Safety of YH14642 Following 12-week Oral Administration in Patients With Chronic Periodontal Disease
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Chronic Periodontitis
Intervention ^ICMJE	Drug: YH14642 500mg Tab YH14642 500mg per day(once a day) Drug: YH14642 500mg Tab YH14642 1000mg per day(twice a day) Drug: YH14642 500mg Tab YH14642 2000mg per day(three times a day) Drug: 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 Drug: DENTISTA[Doxycycline hyclate] 20mg Cap DENTISTA[Doxycycline hyclate] Cap 40mg per day Drug: Placebo Placebo
Study Arm (s)	Experimental: YH14642 A-I Intervention: Drug: YH14642 500mg Tab Experimental: YH14642 A-II Intervention: Drug: YH14642 500mg Tab Experimental: YH14642 A-III Intervention: Drug: YH14642 500mg Tab Active Comparator: Active Comparator B Intervention: Drug: INSADOL[Zea mays L. extract] 35mg Tab Active Comparator: Active Comparator C Intervention: Drug: DENTISTA[Doxycycline hyclate] 20mg Cap Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	162
Completion Date	Not Provided
Estimated Primary Completion Date	July 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	20 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01499225
Other Study ID Numbers ^ICMJE	YH14642-201
Has Data Monitoring Committee	No
Responsible Party	Yuhan Corporation
Study Sponsor ^ICMJE	Yuhan Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yuhan Corporation
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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