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

Phase 4

Completed

• Conditions: Chronic Gastritis; Acute Gastritis
• Interventions: Drug: Stillen Tab.; Drug: Eupasidin-s Tab

• Registration Number: NCT02356679
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-05
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-21
• Last Update Posted: 2015-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stillen tab.	Stillen Tab.	three times per day, 1 tab for each time, PO, during 2weeks
Eupasidin-s tab.	Eupasidin-s Tab	three times per day, 1 tab for each time, PO, during 2weeks

Primary Outcome Measures

Name	Time	Method
cure rate of erosion	2 weeks

Secondary Outcome Measures

Name	Time	Method
improvement rate of erosion	2 weeks
improvement rate of edema	2 weeks
improvement rate of erythema	2 weeks
improvement rate of hemorrhage	2 weeks
improvement rate of self symptoms	2 weeks

Trial Locations

Locations (10)

Inje University Busanpaik hospital; 🇰🇷 Busan, Busangjin, Korea, Republic of

Chonbuk National University Hospital; 🇰🇷 Jeonju, Deokjin-gu, Korea, Republic of

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Ilsan-ro, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Jung-gu, Korea, Republic of

Wonkwang University School of Medicine & Hospital; 🇰🇷 Iksan, Muwang-ro, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Daegu, Nam-gu, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Seo-gu, Korea, Republic of

Dong-A University Hospital; 🇰🇷 Busan, Seo-gu, Korea, Republic of

Hanyang University Medical Center; 🇰🇷 Seoul, Seongdong-gu, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Guangju, Dong-gu, Korea, Republic of