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

Primary Purpose

Acute Gastritis, Chronic Gastritis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Eupasidin-s Tab
Stillen Tab.
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Gastritis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Inje University Busanpaik hospital
  • Chonbuk National University Hospital
  • Chonnam National University Hospital
  • Wonju Severance Christian Hospital
  • Chungnam National University Hospital
  • Wonkwang University School of Medicine & Hospital
  • Yeungnam University Medical Center
  • Kosin University Gospel Hospital
  • Dong-A University Hospital
  • Hanyang University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Eupasidin-s tab.

Stillen tab.

Arm Description

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

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

Outcomes

Primary Outcome Measures

cure rate of erosion

Secondary Outcome Measures

improvement rate of erosion
improvement rate of erythema
improvement rate of hemorrhage
improvement rate of edema
improvement rate of self symptoms

Full Information

First Posted
September 2, 2014
Last Updated
August 21, 2015
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT02356679
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gastritis, Chronic Gastritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eupasidin-s tab.
Arm Type
Experimental
Arm Description
three times per day, 1 tab for each time, PO, during 2weeks
Arm Title
Stillen tab.
Arm Type
Active Comparator
Arm Description
three times per day, 1 tab for each time, PO, during 2weeks
Intervention Type
Drug
Intervention Name(s)
Eupasidin-s Tab
Other Intervention Name(s)
Artemisia herb isopropanol soft ext. 60mg
Intervention Description
three times per day, 1 tab for each time, PO, during 2weeks
Intervention Type
Drug
Intervention Name(s)
Stillen Tab.
Other Intervention Name(s)
Artemisia asiatica 95% ethanol ext. 60mg
Intervention Description
three times per day, 1 tab for each time, PO, during 2weeks
Primary Outcome Measure Information:
Title
cure rate of erosion
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
improvement rate of erosion
Time Frame
2 weeks
Title
improvement rate of erythema
Time Frame
2 weeks
Title
improvement rate of hemorrhage
Time Frame
2 weeks
Title
improvement rate of edema
Time Frame
2 weeks
Title
improvement rate of self symptoms
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age is 19 years old and over, men or women Patients diagnosed with acute or chronic gastritis by gastroscopy and need a treatment for gastritis symptoms Patients with one or more erosions found by gastroscopy Patients who voluntarily signed written informed consent may participate in the study Exclusion Criteria: Patients with peptic ulcer and gastroesophageal reflux disease Patients with Gastrointestinal malignant tumor or surgery related to stomach resection Patients with thromboembolism and coagulation disorder Patients with significant cardiovascular, pulmonary, heptic, renal primary disease 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 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 History of allergic reaction to the investigational product Women either pregnant, breast feeding or possible to pregnant without contraceptive method Use of other investigational drugs within 3 months prior to the study Patients that investigators consider ineligible for this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangyong Seol, Professor
Organizational Affiliation
Inje University Busanpaik Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Busanpaik hospital
City
Busan
State/Province
Busangjin
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
State/Province
Deokjin-gu
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Guangju
State/Province
Dong-gu
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Wonju Severance Christian Hospital
City
Wonju
State/Province
Ilsan-ro
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
State/Province
Jung-gu
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
Wonkwang University School of Medicine & Hospital
City
Iksan
State/Province
Muwang-ro
ZIP/Postal Code
570-711
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
State/Province
Nam-gu
ZIP/Postal Code
705-703
Country
Korea, Republic of
Facility Name
Kosin University Gospel Hospital
City
Busan
State/Province
Seo-gu
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
State/Province
Seo-gu
ZIP/Postal Code
602-812
Country
Korea, Republic of
Facility Name
Hanyang University Medical Center
City
Seoul
State/Province
Seongdong-gu
ZIP/Postal Code
133-792
Country
Korea, Republic of

12. IPD Sharing Statement

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

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