Overview

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

Status:
Completed

Trial end date:
2015-06-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Chong Kun Dang Pharmaceutical

Treatments:

Ethanol

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