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

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

To Evaluate the Efficacy and Safety of CKD-495

Study Overview

• Status: Completed
• Conditions: Gastritis
• Intervention / Treatment: Drug: CKD-495 75mg; Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg; Drug: Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg; Drug: Placebo of the CKD-495 75mg

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 242
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Inje University Busan Paik Hospital
  • Daegu, Korea, Republic of
    • Yeungnam University Medical Center
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of
    • Hanyang University Medical Center
  • Seoul, Korea, Republic of
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of
    • Chung Ang University Hospital
  • Seoul, Korea, Republic of
    • Yeouido St. Mary's Hospital
  • Donggu
    • Gwangju, Donggu, Korea, Republic of
      • Chonnam National University Hospital
  • Gyeongsangbuk-do
    • Daegu, Gyeongsangbuk-do, Korea, Republic of
      • Kyoungpook National University Hospital
  • Seo-gu
    • Busan, Seo-gu, Korea, Republic of
      • Busan National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Patients assigned to this group are treated with one CKD-495 75mg Tab.,and one Placebo Tab.(Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab)	Drug: CKD-495 75mg; CKD-495 75mg Tab.; Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg; Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.
Active Comparator: Active comparator Group; Patients assigned to this group are treated with one Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab, and one Placebo Tab.(Placebo of the CKD-495 75mg)	Drug: Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg; Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab.; Drug: Placebo of the CKD-495 75mg; Placebo of the CKD-495 75mg Tab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement rate of gastric erosion	50% change on erosive grade	14days after drug administrations

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cure rate of gastric erosion	0 erosion	14days after drug administrations
Improvement rate of symptoms	50% change on the Subjective Symptoms total score	14days after drug administrations
Improvement rate of gastric edema	50% change on the Edema grade	14days after drug administrations
Improvement rate of gastric erythema	50% change on the Erythema grade	14days after drug administrations
Improvement rate of gastric hemorrhage	50% change on the Hemorrhage grade	14days after drug administrations

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Oh Young Lee, MD, Ph.D., Hanyang University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): May 20, 2021
• Study Completion (Actual): May 20, 2021

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Chronic Gastritis; Acute Gastritis; Cinnamic acid; CKD-495
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: A74_02AG/CG1904

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No