Status:
COMPLETED
Clinical Trial to Evaluate the Efficacy and Safety of CKD-495 Tablet
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Gastritis
Eligibility:
All Genders
19+ years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2018
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03437785
Start Date
January 16 2018
End Date
October 12 2018
Last Update
October 31 2018
Active Locations (16)
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1
Chonnam National University Hospital
Gwangju, Donggu, Jebongro, South Korea, 501-757
2
Keimyung University Dongsan Medical Center
Daegu, Gyeongsangbuk-do, South Korea
3
Kyungpook National University Hospital
Daegu, Gyeongsangbuk-do, South Korea
4
Kosin University Gospel Hospital
Busan, Seo-gu, South Korea, 602-702