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

Chong Kun Dang

Status and phase: Completed; Phase 2

Conditions: Gastritis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03437785

174AG/CG17002

Details and patient eligibility

About

To Evaluate the Efficacy and Safety of CKD-495

Full 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

Enrollment: 250 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 5 patient groups, including a placebo group

Experimental Group 1

Experimental group

Description:

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.)

Treatment:

Drug: CKD-495 75mg

Drug: Placebo of the Rebamipide 100mg

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

Drug: Placebo of the CKD-495 150mg

Experimental Group 2

Experimental group

Description:

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.)

Treatment:

Drug: Placebo of the Rebamipide 100mg

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

Drug: Placebo of the CKD-495 75mg

Drug: CKD-495 150mg

Placebo Group

Placebo Comparator group

Description:

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.)

Treatment:

Drug: Placebo of the Rebamipide 100mg

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

Drug: Placebo of the CKD-495 150mg

Drug: Placebo of the CKD-495 75mg

Active comparator Group 1

Active Comparator group

Description:

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.)

Treatment:

Drug: Placebo of the Rebamipide 100mg

Drug: Placebo of the CKD-495 150mg

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

Drug: Placebo of the CKD-495 75mg

Active comparator Group 2

Active Comparator group

Description:

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.)

Treatment:

Drug: Rebamipide 100mg

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

Drug: Placebo of the CKD-495 150mg

Drug: Placebo of the CKD-495 75mg