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  • Status : Approved
    • First Submitted Date : 2015/01/19
    • Registered Date : 2015/01/29
    • Last Updated Date : 2015/07/02
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1. Background

Background Information
CRIS
Registration Number
KCT0001366 
Unique Protocol ID MI-IGT-01 
Public/Brief Title A Clinical Trial of the Efficacy and Safety of "Igatan F Capsule"in gingivitis patients or mild to moderate chronic periodontitis patients 
Scientific Title A Double-blind, Randomized, Multicenter, Placebo-controlled Exploratory Clinical Trial of the Efficacy and Safety of "Igatan F Capsule"in gingivitis patients or mild to moderate chronic periodontitis patients  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol No
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
 

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number KHD IRB 1409-02 
Approval Date 2014-09-04 
Institutional Review Board  
Name KYUNGHEE UNIVERSITY DENTAL HOSPITAL Institutional Review Board 
Address  
Telephone  
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Jong Hyuk Chung 
Title DMD, MSD, PhD 
Telephone +82-2-958-9383 
Affiliation Kyung Hee University Dental Hospital 
Address  
Contact Person for Public Queries
Name Jong Hyuk Chung 
Title DMD, MSD, PhD 
Telephone +82-2-958-9383 
Affiliation Kyung Hee University Dental Hospital 
Address  
Contact Person for Updating Information
Name A Ra Cho 
Title Manager 
Telephone +82-2-587-9060 
Affiliation Myungin Pharm 
Address  

4. Status

Status Information
Study Site Multi-center (Number of center : 3)
Overall Recruitment Status Completed  
Date of First Enrollment 2014-11-03 , Actual
Target Number of Participant 100
Primary Completion Date 2015-05-22 , Actual
Study Completion Date 2015-06-30 , Actual
Recruitment Status by Participating Study Site 1
Name of Study Site Kyung Hee University Dental Hospital 
Recruitment Status Completed  
Date of First Enrollment 2014-11-21 , Actual
Recruitment Status by Participating Study Site 2
Name of Study Site Yonseit University Health System, Dental Hospital 
Recruitment Status Completed  
Date of First Enrollment 2014-11-03 , Actual
Recruitment Status by Participating Study Site 3
Name of Study Site Dankook University Dental Hostipal 
Recruitment Status Completed  
Date of First Enrollment 2015-02-26 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Myungin Pharm 
Organization Type Pharmaceutical Company  
Project ID MI-IGT-01 

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Myungin Pharm 
Organization Type Pharmaceutical Company  

7. Study Summary

Study Summary Information
Lay Summary 1. Purpose : to evaluate the efficacy and safety of "IGATAN F Capsule" in gingivitis patients or mild to moderate chronic periodontitis patients
2. Subject : PD(Probing Depth) 4~6mm
3. Methods : Double-blind, Randomized, Multicenter, Placebo-controlled study with Open-extension study
-screening(-4 weeks) + Double blind(4 weeks) + Open extension(4 weeks)
4. Primary endpoint : Gingival Index (compared to baseline(0 week) after 4 weeks with Investigational product)
 

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Treatment    
Phase Phase4 
Intervention Model Parallel  
Blinding/Masking Double 
Blinded Subject Subject, Investigator 
Allocation RCT 
Intervention Type Drug  
Intervention Description 1. Experimental treatment : IGATAN F Capsule, 1Cap*TID*4weeks oral administration->open extension 4weeks( IGATAN F Capsule)
2. Placebo comparator : Placebo Capsule, 1Cap*TID*4weeks oral administration->open extension 4weeks( IGATAN F Capsule)  
Number of Arms
Arm 1 Arm Label Experimental treatment 
Target Number of Participant 50 
Arm Type Experimental 
Arm Description IGATAN F Capsule, 1Cap*TID*4weeks oral administration->open extension 4weeks( IGATAN F Capsule) 
Arm 2 Arm Label Placebo comparator  
Target Number of Participant 50 
Arm Type Placebo comparator 
Arm Description Placebo Capsule, 1Cap*TID*4weeks oral administration->open extension 4weeks( IGATAN F Capsule) 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Diseases of the digestive system
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 19 Year ~ 79 Year
Description 1. Male and female of at least 18 years of age but not older than 80 years
2. PD(Probing Depth) 4~6mm
3. Gingivitis patients or mild to moderate chronic periodontitis patients  
Exclusion Criteria 1. Severe chronic periodontitis patients
2. History of hypersensitivity to IGATAN F Capsule or any related products
3. Any clinical dental treatment(including scaling) in the previous 1 month before day 1 of this study
4. Females are pregnant or lactating
5. Smoker
6. Volunteers who took an Investigational Product in previous 3months before day 1 of this study  
Healthy Volunteers No

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome /Safety/Efficacy 
Primary Outcome(s) 1 
Outcome Gingival Index 
Timepoint compared to baseline(0 week) after 4 weeks with Investigational product 
Secondary Outcome(s) 1 
Outcome Plaque Index 
Timepoint compared to baseline(0 week) after 4 weeks with Investigational product 
Secondary Outcome(s) 2 
Outcome Clinical Attachment Level 
Timepoint compared to baseline(0 week) after 4 weeks with Investigational product 
Secondary Outcome(s) 3 
Outcome Bleeding On Probing 
Timepoint compared to baseline(0 week) after 4 weeks with Investigational product 
Secondary Outcome(s) 4 
Outcome Probing Depth 
Timepoint compared to baseline(0 week) after 4 weeks with Investigational product 
Secondary Outcome(s) 5 
Outcome Gingival Enlargement 
Timepoint compared to baseline(0 week) after 4 weeks with Investigational product 
Secondary Outcome(s) 6 
Outcome Gingival Recession 
Timepoint compared to baseline(0 week) after 4 weeks with Investigational product 
Secondary Outcome(s) 7 
Outcome 100mm VAS (Visual Analogue Scale) 
Timepoint compared to baseline(0 week) after 4 weeks with Investigational product 
Secondary Outcome(s) 8 
Outcome Measure Vital Sign 
Timepoint compared to baseline(0 week) with last visit 

11. Study Results and Publication

Study Results and Publication Information
Result Registerd  

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement Not provided at time of Registration 
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