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NCT03437785 Clinical Trial

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

Gastritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03437785
Other study ID # 174AG/CG17002
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 16, 2018
Est. completion date October 12, 2018

Study information
Verified date February 2018
Source Chong Kun Dang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To Evaluate the Efficacy and Safety of CKD-495

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

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date October 12, 2018
Est. primary completion date October 12, 2018
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CKD-495 75mg
CKD-495 75mg Tab.
• CKD-495 150mg
CKD-495 150mg Tab.
• Artemisiae argyi folium 95% ethanol ext.(20?1) 60mg
Artemisiae argyi folium 95% ethanol ext.(20?1) 60mg Tab.
• Rebamipide 100mg
Rebamipide 100mg Tab.
• Placebo of the CKD-495 75mg
Placebo of the CKD-495 75mg Tab.
• Placebo of the CKD-495 150mg
Placebo of the CKD-495 150mg Tab.
• Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20?1) 60mg
Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20?1) 60mg Tab.
• Placebo of the Rebamipide 100mg
Placebo of the Rebamipide 100mg Tab

Locations
Country Name City State
Korea, Republic of Busan National University Hospital Busan
Korea, Republic of Inje University Busan Paik Hospital Busan
Korea, Republic of Kosin University Gospel Hospital Busan Seo-gu
Korea, Republic of Hallym University Chuncheon Seonsim Hospital Chuncheon
Korea, Republic of Keimyung University Dongsan Medical Center Daegu Gyeongsangbuk-do
Korea, Republic of Kyungpook National University Hospital Daegu Gyeongsangbuk-do
Korea, Republic of Yeungnam University Medical Center Daegu
Korea, Republic of Chonnam National University Hospital Gwangju Donggu, Jebongro
Korea, Republic of Wonkwang University Hospital Iksan
Korea, Republic of Jeju National University Hospital Jeju
Korea, Republic of Chonbuk National University Hospital Jeonju
Korea, Republic of Seoul National University Bundang Hospital Seongnam
Korea, Republic of Hanyang University Hospital Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement rate of gastric erosion 50% decreased on erosive grade 14days after drug administrations
Secondary cure rate of gastric erosion 0 erosion 14days after drug administrations
Secondary Improvement rate of symptoms 50% decreased on the Subjective Symptoms total score 14days after drug administrations
Secondary Improvement rate of gastric edema 50% decreased on the Edema grade 14days after drug administrations
Secondary Improvement rate of gastric erythema 50% decreased on the Erythema grade 14days after drug administrations
Secondary Improvement rate of gastric hemorrhage 50% decreased on the Hemorrhage grade 14days after drug administrations
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