Clinical trial NCT03437785: Clinical Trial to Evaluate the Efficacy and Safety of CKD-495 Tablet
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastritis
Keywords: Acute Gastritis
Chronic Gastritis
Cinnamic acid
CKD-495
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 250
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 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 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, Jebongro
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
state: Gyeongsangbuk-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Gyeongsangbuk-do
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
state: Seo-gu
city: Busan
country: Korea, Republic of
facility: Busan National University Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Chuncheon
country: Korea, Republic of
facility: Hallym University Chuncheon Seonsim Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
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: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: