Clinical trial NCT02356679: Efficacy and Safety of Eupasidin-s Tab.(EUPASIDIN-S) in Gastritis Patients
Official title: A Phase 4, Multicenter, Randomized, Open, Active Drug Comparative Trial to Evaluated the Efficacy and Safety of EUPASIDIN-S Tab. in Gastritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Gastritis
Chronic Gastritis
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-02-05
Enrollment: 230
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: The purpose of this study is evaluate the Efficacy and Safety of EUPASIDIN-S Tab. in Gastritis Patients.


Eligibility criteria: Inclusion Criteria:

1. Age is 19 years old and over, men or women
2. Patients diagnosed with acute or chronic gastritis by gastroscopy and need a treatment for gastritis symptoms
3. Patients with one or more erosions found by gastroscopy
4. Patients who voluntarily signed written informed consent may participate in the study

Exclusion Criteria:

1. Patients with peptic ulcer and gastroesophageal reflux disease
2. Patients with Gastrointestinal malignant tumor or surgery related to stomach resection
3. Patients with thromboembolism and coagulation disorder
4. Patients with significant cardiovascular, pulmonary, heptic, renal primary disease
5. Patients with abnormal laboratory result at screening

   * Aspartate aminotransferase(AST), Alanine aminotransferase(ALT), Creatinine \> upper limit of normal range x 2
   * White blood cell(WBC) \< 4,000/mm3
   * Platelet \< 50,000/mm3
6. Patients administered with H2 receptor antagonists, proton pump inhibitors, muscarine receptor antagonists, other gastiritis treatment drug, protective factor builder, non-steroid anti-inflammatory drugs prior to study in 2 weeks
7. History of allergic reaction to the investigational product
8. Women either pregnant, breast feeding or possible to pregnant without contraceptive method
9. Use of other investigational drugs within 3 months prior to the study
10. Patients that investigators consider ineligible for this study

Primary outcomes:
measure: cure rate of erosion
timeFrame: 2 weeks
Secondary outcomes:
measure: improvement rate of erosion
timeFrame: 2 weeks
measure: improvement rate of erythema
timeFrame: 2 weeks
measure: improvement rate of hemorrhage
timeFrame: 2 weeks
measure: improvement rate of edema
timeFrame: 2 weeks
measure: improvement rate of self symptoms
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busanpaik hospital
state: Busangjin
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Deokjin-gu
city: Guangju
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Dong-gu
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Ilsan-ro
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
state: Jung-gu
city: Iksan
country: Korea, Republic of
facility: Wonkwang University School of Medicine & Hospital
state: Muwang-ro
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
state: Nam-gu
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
state: Seo-gu
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
state: Seo-gu
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
state: Seongdong-gu
Study officials:
affiliation: Inje University Busanpaik Hospital
name: Sangyong Seol, Professor
role: PRINCIPAL_INVESTIGATOR
References: