Clinical trial NCT04255589: A Clinical Trial to Evaluate the Efficacy and Safety of CKD-495
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastritis
Keywords: Acute Gastritis
Chronic Gastritis
Cinnamic acid
CKD-495
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 242
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Improvement rate of gastric erosion
timeFrame: 14days after drug administrations
Secondary outcomes:
measure: cure rate of gastric erosion
timeFrame: 14days after drug administrations
measure: Improvement rate of symptoms
timeFrame: 14days after drug administrations
measure: Improvement rate of gastric edema
timeFrame: 14days after drug administrations
measure: Improvement rate of gastric erythema
timeFrame: 14days after drug administrations
measure: Improvement rate of gastric hemorrhage
timeFrame: 14days after drug administrations
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Donggu
city: Daegu
country: Korea, Republic of
facility: Kyoungpook National University Hospital
state: Gyeongsangbuk-do
city: Busan
country: Korea, Republic of
facility: Busan National University Hospital
state: Seo-gu
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Chung Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yeouido ST. Mary's Hospital
Study officials:
affiliation: Hanyang University
name: Oh Young Lee, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: