Efficacy and Safety of Eupasidin-s Tab.(EUPASIDIN-S) in Gastritis Patients

Chong Kun Dang

Status and phase: Completed; Phase 4

Conditions: Chronic Gastritis; Acute Gastritis

Treatments: Drug: Stillen Tab.; Drug: Eupasidin-s Tab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02356679

EUPASIDIN-S_P4

Details and patient eligibility

About

The purpose of this study is evaluate the Efficacy and Safety of EUPASIDIN-S Tab. in Gastritis Patients.

Enrollment: 230 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Eupasidin-s tab.

Experimental group

Description:

three times per day, 1 tab for each time, PO, during 2weeks

Treatment:

Drug: Eupasidin-s Tab

Stillen tab.

Active Comparator group

Description:

three times per day, 1 tab for each time, PO, during 2weeks

Treatment:

Drug: Stillen Tab.