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

A Phase 3, Multi-center, Randomized, Double-blind, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-495 in Patients With Acute and Chronic Gastritis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04255589

Enrollment

242

Registered

2020-02-05

Start date

2020-01-06

Completion date

2021-05-20

Last updated

2021-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastritis

Keywords

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

Brief summary

To Evaluate the Efficacy and Safety of CKD-495

Detailed description

A phase 3, Multi-center, Randomized, Double-blind, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-495 in Patients With Acute and Chronic Gastritis

Interventions

DRUGCKD-495 75mg

CKD-495 75mg Tab.

DRUGArtemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg

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

DRUGPlacebo of the CKD-495 75mg

Placebo of the CKD-495 75mg Tab.

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Improvement rate of gastric erosion	14days after drug administrations	50% change on erosive grade

Secondary

Measure	Time frame	Description
Improvement rate of symptoms	14days after drug administrations	50% change on the Subjective Symptoms total score
Improvement rate of gastric edema	14days after drug administrations	50% change on the Edema grade
Improvement rate of gastric erythema	14days after drug administrations	50% change on the Erythema grade
Improvement rate of gastric hemorrhage	14days after drug administrations	50% change on the Hemorrhage grade
cure rate of gastric erosion	14days after drug administrations	0 erosion

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026