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

C

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

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

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

Trial contacts and locations

16

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems