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

NCT ID: NCT03437785

Last Updated: 2018-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-16

Study Completion Date

2018-10-12

Brief Summary

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To Evaluate the Efficacy and Safety of CKD-495

Detailed Description

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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

Conditions

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Gastritis

Keywords

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Acute Gastritis Chronic Gastritis Cinnamic acid CKD-495

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.)

Group Type EXPERIMENTAL

CKD-495 75mg

Intervention Type DRUG

CKD-495 75mg Tab.

Placebo of the CKD-495 150mg

Intervention Type DRUG

Placebo of the CKD-495 150mg Tab.

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

Intervention Type DRUG

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

Placebo of the Rebamipide 100mg

Intervention Type DRUG

Placebo of the Rebamipide 100mg Tab

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.)

Group Type EXPERIMENTAL

CKD-495 150mg

Intervention Type DRUG

CKD-495 150mg Tab.

Placebo of the CKD-495 75mg

Intervention Type DRUG

Placebo of the CKD-495 75mg Tab.

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

Intervention Type DRUG

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

Placebo of the Rebamipide 100mg

Intervention Type DRUG

Placebo of the Rebamipide 100mg Tab

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.)

Group Type PLACEBO_COMPARATOR

Placebo of the CKD-495 75mg

Intervention Type DRUG

Placebo of the CKD-495 75mg Tab.

Placebo of the CKD-495 150mg

Intervention Type DRUG

Placebo of the CKD-495 150mg Tab.

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

Intervention Type DRUG

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

Placebo of the Rebamipide 100mg

Intervention Type DRUG

Placebo of the Rebamipide 100mg Tab

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.)

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Placebo of the CKD-495 75mg

Intervention Type DRUG

Placebo of the CKD-495 75mg Tab.

Placebo of the CKD-495 150mg

Intervention Type DRUG

Placebo of the CKD-495 150mg Tab.

Placebo of the Rebamipide 100mg

Intervention Type DRUG

Placebo of the Rebamipide 100mg Tab

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.)

Group Type ACTIVE_COMPARATOR

Rebamipide 100mg

Intervention Type DRUG

Rebamipide 100mg Tab.

Placebo of the CKD-495 75mg

Intervention Type DRUG

Placebo of the CKD-495 75mg Tab.

Placebo of the CKD-495 150mg

Intervention Type DRUG

Placebo of the CKD-495 150mg Tab.

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

Intervention Type DRUG

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

Interventions

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CKD-495 75mg

CKD-495 75mg Tab.

Intervention Type DRUG

CKD-495 150mg

CKD-495 150mg Tab.

Intervention Type DRUG

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

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

Intervention Type DRUG

Rebamipide 100mg

Rebamipide 100mg Tab.

Intervention Type DRUG

Placebo of the CKD-495 75mg

Placebo of the CKD-495 75mg Tab.

Intervention Type DRUG

Placebo of the CKD-495 150mg

Placebo of the CKD-495 150mg Tab.

Intervention Type DRUG

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

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

Intervention Type DRUG

Placebo of the Rebamipide 100mg

Placebo of the Rebamipide 100mg Tab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chonnam National University Hospital

Gwangju, Donggu, Jebongro, South Korea

Site Status

Keimyung University Dongsan Medical Center

Daegu, Gyeongsangbuk-do, South Korea

Site Status

Kyungpook National University Hospital

Daegu, Gyeongsangbuk-do, South Korea

Site Status

Kosin University Gospel Hospital

Busan, Seo-gu, South Korea

Site Status

Busan National University Hospital

Busan, , South Korea

Site Status

Inje University Busan Paik Hospital

Busan, , South Korea

Site Status

Hallym University Chuncheon Seonsim Hospital

Chuncheon, , South Korea

Site Status

Yeungnam University Medical Center

Daegu, , South Korea

Site Status

Wonkwang University Hospital

Iksan, , South Korea

Site Status

Jeju National University Hospital

Jeju City, , South Korea

Site Status

Chonbuk National University Hospital

Jeonju, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Hanyang University Hospital

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 40255536 (View on PubMed)

Other Identifiers

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174AG/CG17002

Identifier Type: -

Identifier Source: org_study_id