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

NCT03437785 | Completed Phase 2

• 1 other identifier: 174AG/CG17002
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 16

Brief Summary

To Evaluate the Efficacy and Safety of CKD-495

Conditions

Gastritis

Keywords

Acute Gastritis; Chronic Gastritis; Cinnamic acid; CKD-495

Outcome Measures

Primary Outcomes (1)

• Improvement rate of gastric erosion

  50% decreased on erosive grade

  14days after drug administrations

Secondary Outcomes (5)

• cure rate of gastric erosion

  14days after drug administrations

• Improvement rate of symptoms

  14days after drug administrations

• Improvement rate of gastric edema

  14days after drug administrations

• Improvement rate of gastric erythema

  14days after drug administrations

• Improvement rate of gastric hemorrhage

  14days after drug administrations

Study Arms (5)

Experimental Group 1

EXPERIMENTAL

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; Drug: Placebo of the CKD-495 150mg; Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg; Drug: Placebo of the Rebamipide 100mg

Experimental Group 2

EXPERIMENTAL

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: CKD-495 150mg; Drug: Placebo of the CKD-495 75mg; Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg; Drug: Placebo of the Rebamipide 100mg

Placebo Group

PLACEBO COMPARATOR

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 the CKD-495 75mg; Drug: Placebo of the CKD-495 150mg; Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg; Drug: Placebo of the Rebamipide 100mg

Active comparator Group 1

ACTIVE COMPARATOR

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

Active comparator Group 2

ACTIVE COMPARATOR

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: Rebamipide 100mg; Drug: Placebo of the CKD-495 75mg; Drug: Placebo of the CKD-495 150mg; Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg

Interventions

CKD-495 75mg DRUG

CKD-495 75mg Tab.

Experimental Group 1

CKD-495 150mg DRUG

CKD-495 150mg Tab.

Experimental Group 2

Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg DRUG

Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab.

Active comparator Group 1

Rebamipide 100mg DRUG

Rebamipide 100mg Tab.

Active comparator Group 2

Placebo of the CKD-495 75mg DRUG

Placebo of the CKD-495 75mg Tab.

Active comparator Group 1; Active comparator Group 2; Experimental Group 2; Placebo Group

Placebo of the CKD-495 150mg DRUG

Placebo of the CKD-495 150mg Tab.

Active comparator Group 1; Active comparator Group 2; Experimental Group 1; Placebo Group

Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg DRUG

Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.

Active comparator Group 2; Experimental Group 1; Experimental Group 2; Placebo Group

Placebo of the Rebamipide 100mg DRUG

Placebo of the Rebamipide 100mg Tab

Active comparator Group 1; Experimental Group 1; Experimental Group 2; Placebo Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (16)

Chonnam National University Hospital

Gwangju, Donggu, Jebongro, 501-757, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, Gyeongsangbuk-do, South Korea

Location

Kyungpook National University Hospital

Daegu, Gyeongsangbuk-do, South Korea

Location

Kosin University Gospel Hospital

Busan, Seo-gu, 602-702, South Korea

Location

Busan National University Hospital

Busan, South Korea

Location

Inje University Busan Paik Hospital

Busan, South Korea

Location

Hallym University Chuncheon Seonsim Hospital

Chuncheon, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Wonkwang University Hospital

Iksan, South Korea

Location

Jeju National University Hospital

Jeju City, South Korea

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Hanyang University Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Related Publications (1)

• Park SH, Lee OY, Lee YC, Park KS, Park JJ, Park MI, Song GA, Lee DH, Jung H, Kim SK, Kim TN, Choi SC, Jee SR, Rew JS, Lee ST, Choi EK, Baik GH, Park SJ. 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. Can J Gastroenterol Hepatol. 2025 Apr 10;2025:2702089. doi: 10.1155/cjgh/2702089. eCollection 2025.

  PMID: 40255536 DERIVED

MeSH Terms

Conditions

Gastritis

Interventions

rebamipide

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 19, 2018
• Study Start: January 16, 2018
• Primary Completion: October 12, 2018
• Study Completion: October 12, 2018
• Last Updated: October 31, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (16)