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
1 other identifier
interventional
242
1 country
17
Brief Summary
To Evaluate the Efficacy and Safety of CKD-495
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2020
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 6, 2020
CompletedFirst Submitted
Initial submission to the registry
February 3, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2021
CompletedJuly 2, 2021
June 1, 2021
1.4 years
February 3, 2020
June 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement rate of gastric erosion
50% change on erosive grade
14days after drug administrations
Secondary Outcomes (5)
cure rate of gastric erosion
14days after drug administrations
Improvement rate of symptoms
14days after drug administrations
Improvement rate of gastric edema
14days after drug administrations
Improvement rate of gastric erythema
14days after drug administrations
Improvement rate of gastric hemorrhage
14days after drug administrations
Study Arms (2)
Experimental Group
EXPERIMENTALPatients assigned to this group are treated with one CKD-495 75mg Tab.,and one Placebo Tab.(Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab)
Active comparator Group
ACTIVE COMPARATORPatients assigned to this group are treated with one Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab, and one Placebo Tab.(Placebo of the CKD-495 75mg)
Interventions
Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab.
Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Chonnam National University Hospital
Gwangju, Donggu, South Korea
Kyoungpook National University Hospital
Daegu, Gyeongsangbuk-do, South Korea
Busan National University Hospital
Busan, Seo-gu, South Korea
Inje University Busan Paik Hospital
Busan, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Chung Ang University Hospital
Seoul, South Korea
Hanyang University Medical Center
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, South Korea
Yeouido ST. Mary's Hospital
Seoul, South Korea
Related Publications (1)
Seo SY, Lee ST, Kim SK, Chun HJ, Song GA, Lee DH, Kim JJ, Kim JI, Lee YC, Kim TN, Jee SR, Park SY, Kim JG, Park JJ, Kim SG, Park JM, Park JH, Park SJ, Lee OY. Efficacy and safety of CKD-495 in acute and chronic gastritis: A Phase III superiority clinical trial. Medicine (Baltimore). 2023 Dec 8;102(49):e35926. doi: 10.1097/MD.0000000000035926.
PMID: 38065906DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oh Young Lee, MD, Ph.D.
Hanyang University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2020
First Posted
February 5, 2020
Study Start
January 6, 2020
Primary Completion
May 20, 2021
Study Completion
May 20, 2021
Last Updated
July 2, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share