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Clinical Trial to Evaluate the Efficacy and Safety of CKD-495 Tablet

Primary Purpose

Gastritis

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-495 75mg
CKD-495 150mg
Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg
Rebamipide 100mg
Placebo of the CKD-495 75mg
Placebo of the CKD-495 150mg
Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg
Placebo of the Rebamipide 100mg
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastritis focused on measuring Acute Gastritis, Chronic Gastritis, Cinnamic acid, CKD-495

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or Female subjects aged ≥ 19
  2. Acute or Chronic gastritis patients who have more than 1 erosion on endoscopy within 7days prior to the use of the Investigator's Product taken date
  3. Patients who have more than 1 subjective symptom

Exclusion Criteria:

  1. Patients with peptic ulcer, gastroesophageal reflux disease, malignant tumor in the digestive system or coagulation disorder, or taking antithrombotic medicine
  2. Patients who have been taken any gastritis medicine that could affect the treatment: H2 receptor antagonist, PPI(Proton Pump Inhibitor), antacid, improvement of movement in digestive system, Prostaglandin, and protective agent for gastritis
  3. Patients who have to take medicine that could cause gastritis

Sites / Locations

  • Chonnam National University Hospital
  • Keimyung University Dongsan Medical Center
  • Kyungpook National University Hospital
  • Kosin University Gospel Hospital
  • Busan National University Hospital
  • Inje University Busan Paik Hospital
  • Hallym University Chuncheon Seonsim Hospital
  • Yeungnam University Medical Center
  • Wonkwang University Hospital
  • Jeju National University Hospital
  • Chonbuk National University Hospital
  • Seoul National University Bundang Hospital
  • Hanyang University Hospital
  • Korea University Guro Hospital
  • Seoul National University Hospital
  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Experimental Group 1

Experimental Group 2

Placebo Group

Active comparator Group 1

Active comparator Group 2

Arm Description

Patients assigned to this group are treated with CKD-495 75mg Tab.,and other 3 Placebo Tab.(Placebo of the CKD-495 150mg, ,Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab., Placebo of the Rebamipide 100mg Tab.)

Patients assigned to this group are treated with CKD-495 150mg Tab.,and other 3 Placebo Tab.(Placebo of the CKD-495 75mg, Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab., Placebo of the Rebamipide 100mg Tab.)

Patients assigned to this group are treated with 4 Placebo Tab.(Placebo of the CKD-495 75mg, Placebo of the CKD-495 150mg, Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab., Placebo of the Rebamipide 100mg Tab.)

Patients assigned to this group are treated with Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab, and other 3 Placebo Tab.(Placebo of the CKD-495 75mg, Placebo of the CKD-495 150mg, Placebo of the Rebamipide 100mg Tab.)

Patients assigned to this group are treated with Rebamipide 100mg Tab.,and other 3 Placebo Tab.(Placebo of the CKD-495 75mg, Placebo of the CKD-495 150mg, Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.)

Outcomes

Primary Outcome Measures

Improvement rate of gastric erosion
50% decreased on erosive grade

Secondary Outcome Measures

cure rate of gastric erosion
0 erosion
Improvement rate of symptoms
50% decreased on the Subjective Symptoms total score
Improvement rate of gastric edema
50% decreased on the Edema grade
Improvement rate of gastric erythema
50% decreased on the Erythema grade
Improvement rate of gastric hemorrhage
50% decreased on the Hemorrhage grade

Full Information

First Posted
February 13, 2018
Last Updated
October 29, 2018
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT03437785
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of CKD-495 Tablet
Official Title
A Phase 2, Multi-center, Randomized, Double-blind, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-495 in Patients With Acute and Chronic Gastritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 16, 2018 (Actual)
Primary Completion Date
October 12, 2018 (Actual)
Study Completion Date
October 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To Evaluate the Efficacy and Safety of CKD-495
Detailed Description
A Phase 2, Multi-center, Randomized, Double-blind, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-495 in Patients with Acute and Chronic Gastritis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastritis
Keywords
Acute Gastritis, Chronic Gastritis, Cinnamic acid, CKD-495

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group 1
Arm Type
Experimental
Arm Description
Patients assigned to this group are treated with CKD-495 75mg Tab.,and other 3 Placebo Tab.(Placebo of the CKD-495 150mg, ,Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab., Placebo of the Rebamipide 100mg Tab.)
Arm Title
Experimental Group 2
Arm Type
Experimental
Arm Description
Patients assigned to this group are treated with CKD-495 150mg Tab.,and other 3 Placebo Tab.(Placebo of the CKD-495 75mg, Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab., Placebo of the Rebamipide 100mg Tab.)
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Patients assigned to this group are treated with 4 Placebo Tab.(Placebo of the CKD-495 75mg, Placebo of the CKD-495 150mg, Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab., Placebo of the Rebamipide 100mg Tab.)
Arm Title
Active comparator Group 1
Arm Type
Active Comparator
Arm Description
Patients assigned to this group are treated with Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab, and other 3 Placebo Tab.(Placebo of the CKD-495 75mg, Placebo of the CKD-495 150mg, Placebo of the Rebamipide 100mg Tab.)
Arm Title
Active comparator Group 2
Arm Type
Active Comparator
Arm Description
Patients assigned to this group are treated with Rebamipide 100mg Tab.,and other 3 Placebo Tab.(Placebo of the CKD-495 75mg, Placebo of the CKD-495 150mg, Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.)
Intervention Type
Drug
Intervention Name(s)
CKD-495 75mg
Intervention Description
CKD-495 75mg Tab.
Intervention Type
Drug
Intervention Name(s)
CKD-495 150mg
Intervention Description
CKD-495 150mg Tab.
Intervention Type
Drug
Intervention Name(s)
Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg
Intervention Description
Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab.
Intervention Type
Drug
Intervention Name(s)
Rebamipide 100mg
Intervention Description
Rebamipide 100mg Tab.
Intervention Type
Drug
Intervention Name(s)
Placebo of the CKD-495 75mg
Intervention Description
Placebo of the CKD-495 75mg Tab.
Intervention Type
Drug
Intervention Name(s)
Placebo of the CKD-495 150mg
Intervention Description
Placebo of the CKD-495 150mg Tab.
Intervention Type
Drug
Intervention Name(s)
Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg
Intervention Description
Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.
Intervention Type
Drug
Intervention Name(s)
Placebo of the Rebamipide 100mg
Intervention Description
Placebo of the Rebamipide 100mg Tab
Primary Outcome Measure Information:
Title
Improvement rate of gastric erosion
Description
50% decreased on erosive grade
Time Frame
14days after drug administrations
Secondary Outcome Measure Information:
Title
cure rate of gastric erosion
Description
0 erosion
Time Frame
14days after drug administrations
Title
Improvement rate of symptoms
Description
50% decreased on the Subjective Symptoms total score
Time Frame
14days after drug administrations
Title
Improvement rate of gastric edema
Description
50% decreased on the Edema grade
Time Frame
14days after drug administrations
Title
Improvement rate of gastric erythema
Description
50% decreased on the Erythema grade
Time Frame
14days after drug administrations
Title
Improvement rate of gastric hemorrhage
Description
50% decreased on the Hemorrhage grade
Time Frame
14days after drug administrations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or Female subjects aged ≥ 19 Acute or Chronic gastritis patients who have more than 1 erosion on endoscopy within 7days prior to the use of the Investigator's Product taken date Patients who have more than 1 subjective symptom Exclusion Criteria: Patients with peptic ulcer, gastroesophageal reflux disease, malignant tumor in the digestive system or coagulation disorder, or taking antithrombotic medicine Patients who have been taken any gastritis medicine that could affect the treatment: H2 receptor antagonist, PPI(Proton Pump Inhibitor), antacid, improvement of movement in digestive system, Prostaglandin, and protective agent for gastritis Patients who have to take medicine that could cause gastritis
Facility Information:
Facility Name
Chonnam National University Hospital
City
Gwangju
State/Province
Donggu, Jebongro
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
State/Province
Gyeongsangbuk-do
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
State/Province
Gyeongsangbuk-do
Country
Korea, Republic of
Facility Name
Kosin University Gospel Hospital
City
Busan
State/Province
Seo-gu
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Busan National University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Hallym University Chuncheon Seonsim Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Wonkwang University Hospital
City
Iksan
Country
Korea, Republic of
Facility Name
Jeju National University Hospital
City
Jeju
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Hanyang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Trial to Evaluate the Efficacy and Safety of CKD-495 Tablet

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