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

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

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: Placebo of the CKD-495 75mg; Drug: Placebo of the CKD-495 150mg; Drug: Placebo of the Rebamipide 100mg; Drug: CKD-495 150mg; Drug: Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg; Drug: Rebamipide 100mg

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

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Inje University Busan Paik Hospital
  • Busan, Korea, Republic of
    • Busan National University Hospital
  • Chuncheon, Korea, Republic of
    • Hallym University Chuncheon Seonsim Hospital
  • Daegu, Korea, Republic of
    • Yeungnam University Medical Center
  • Iksan, Korea, Republic of
    • Wonkwang University Hospital
  • Jeju, Korea, Republic of
    • Jeju National University Hospital
  • 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
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Hanyang University Hospital
  • Donggu, Jebongro
    • Gwangju, Donggu, Jebongro, Korea, Republic of, 501-757
      • Chonnam National University Hospital
  • Gyeongsangbuk-do
    • Daegu, Gyeongsangbuk-do, Korea, Republic of
      • Keimyung University Dongsan Medical Center
    • Daegu, Gyeongsangbuk-do, Korea, Republic of
      • Kyungpook National University Hospital
  • Seo-gu
    • Busan, Seo-gu, Korea, Republic of, 602-702
      • Kosin University Gospel Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 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
• Masking: DOUBLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental Group 1; 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.)	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.; Drug: Placebo of the CKD-495 150mg; Placebo of the CKD-495 150mg Tab.; Drug: Placebo of the Rebamipide 100mg; Placebo of the Rebamipide 100mg Tab
EXPERIMENTAL: Experimental Group 2; 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.)	Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg; Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.; Drug: Placebo of the CKD-495 75mg; Placebo of the CKD-495 75mg Tab.; Drug: Placebo of the Rebamipide 100mg; Placebo of the Rebamipide 100mg Tab; Drug: CKD-495 150mg; CKD-495 150mg Tab.
PLACEBO_COMPARATOR: Placebo Group; 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.)	Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg; Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.; Drug: Placebo of the CKD-495 75mg; Placebo of the CKD-495 75mg Tab.; Drug: Placebo of the CKD-495 150mg; Placebo of the CKD-495 150mg Tab.; Drug: Placebo of the Rebamipide 100mg; Placebo of the Rebamipide 100mg Tab
ACTIVE_COMPARATOR: Active comparator Group 1; 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.)	Drug: Placebo of the CKD-495 75mg; Placebo of the CKD-495 75mg Tab.; Drug: Placebo of the CKD-495 150mg; Placebo of the CKD-495 150mg Tab.; Drug: Placebo of the Rebamipide 100mg; Placebo of the Rebamipide 100mg Tab; Drug: Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg; Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab.
ACTIVE_COMPARATOR: Active comparator Group 2; 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.)	Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg; Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.; Drug: Placebo of the CKD-495 75mg; Placebo of the CKD-495 75mg Tab.; Drug: Placebo of the CKD-495 150mg; Placebo of the CKD-495 150mg Tab.; Drug: Rebamipide 100mg; Rebamipide 100mg Tab.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 16, 2018
• Primary Completion (ACTUAL): October 12, 2018
• Study Completion (ACTUAL): October 12, 2018

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (ACTUAL): February 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 29, 2018
• Last Verified: February 1, 2018

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; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Enzyme Inhibitors; Gastrointestinal Agents; Protective Agents; Anti-Ulcer Agents; Antioxidants; Ethanol; Rebamipide
• Other Study ID Numbers: 174AG/CG17002

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