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

Gastritis Clinical Trial

Official title:

A Phase 3, 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: NCT04255589
• Other study ID #: A74_02AG/CG1904
• Status: Completed
• Phase: Phase 3
• Start date: January 6, 2020
• Est. completion date: May 20, 2021

Study information

• Verified date: June 2021
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To Evaluate the Efficacy and Safety of CKD-495

Description:

A phase 3, 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: 242
• Est. completion date: May 20, 2021
• Est. primary completion date: May 20, 2021
• 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

Related Conditions & MeSH terms

• Gastritis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Busan National University Hospital	Busan	Seo-gu
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Kyoungpook National University Hospital	Daegu	Gyeongsangbuk-do
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Chonnam National University Hospital	Gwangju	Donggu
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Chung Ang University Hospital	Seoul
Korea, Republic of	Hanyang University Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul ST. Mary's Hospital	Seoul
Korea, Republic of	Yeouido ST. Mary's 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% change 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% change on the Subjective Symptoms total score	14days after drug administrations
Secondary	Improvement rate of gastric edema	50% change on the Edema grade	14days after drug administrations
Secondary	Improvement rate of gastric erythema	50% change on the Erythema grade	14days after drug administrations
Secondary	Improvement rate of gastric hemorrhage	50% change on the Hemorrhage grade	14days after drug administrations