Gastritis
Conditions
Keywords
Acute Gastritis, Chronic Gastritis, Cinnamic acid, CKD-495
Brief summary
To Evaluate the Efficacy and Safety of CKD-495
Detailed 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
Interventions
DRUGCKD-495 75mg
CKD-495 75mg Tab.
DRUGCKD-495 150mg
CKD-495 150mg Tab.
DRUGArtemisiae argyi folium 95% ethanol ext.(20→1) 60mg
Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab.
DRUGRebamipide 100mg
Rebamipide 100mg Tab.
Placebo of the CKD-495 75mg Tab.
DRUGPlacebo of the CKD-495 150mg
Placebo of the CKD-495 150mg Tab.
Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.
DRUGPlacebo of the Rebamipide 100mg
Placebo of the Rebamipide 100mg Tab
Sponsors
Chong Kun Dang Pharmaceutical
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
No
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% decreased on erosive grade |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cure rate of gastric erosion | 14days after drug administrations | 0 erosion |
| Improvement rate of symptoms | 14days after drug administrations | 50% decreased on the Subjective Symptoms total score |
| Improvement rate of gastric edema | 14days after drug administrations | 50% decreased on the Edema grade |
| Improvement rate of gastric erythema | 14days after drug administrations | 50% decreased on the Erythema grade |
| Improvement rate of gastric hemorrhage | 14days after drug administrations | 50% decreased on the Hemorrhage grade |
Countries
South Korea
Outcome results
None listed