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

A Phase 4, Multicenter, Randomized, Open, Active Drug Comparative Trial to Evaluated the Efficacy and Safety of EUPASIDIN-S Tab. in Gastritis Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02356679

Enrollment

230

Registered

2015-02-05

Start date

2014-08-31

Completion date

2015-06-30

Last updated

2015-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Gastritis, Chronic Gastritis

Brief summary

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

Interventions

DRUGEupasidin-s Tab

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

DRUGStillen Tab.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
cure rate of erosion	2 weeks

Secondary

Measure	Time frame
improvement rate of erosion	2 weeks
improvement rate of erythema	2 weeks
improvement rate of hemorrhage	2 weeks
improvement rate of edema	2 weeks
improvement rate of self symptoms	2 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026