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

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT02356679
Collaborator
(none)
230
Enrollment
10
Locations
2
Arms
10
Duration (Months)
23
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Eupasidin-s Tab
  • Drug: Stillen Tab.
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
230 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Eupasidin-s tab.

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

Drug: Eupasidin-s Tab
three times per day, 1 tab for each time, PO, during 2weeks
Other Names:
  • Artemisia herb isopropanol soft ext. 60mg

    		•
    Active Comparator: Stillen tab.

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

    Drug: Stillen Tab.
    three times per day, 1 tab for each time, PO, during 2weeks
    Other Names:
  • Artemisia asiatica 95% ethanol ext. 60mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. cure rate of erosion [2 weeks]

    Secondary Outcome Measures

    1. improvement rate of erosion [2 weeks]

    2. improvement rate of erythema [2 weeks]

    3. improvement rate of hemorrhage [2 weeks]

    4. improvement rate of edema [2 weeks]

    5. improvement rate of self symptoms [2 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. 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

    2. History of allergic reaction to the investigational product

    3. Women either pregnant, breast feeding or possible to pregnant without contraceptive method

    4. Use of other investigational drugs within 3 months prior to the study

    5. Patients that investigators consider ineligible for this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Inje University Busanpaik hospital Busan Busangjin Korea, Republic of 614-735
    2 Chonbuk National University Hospital Jeonju Deokjin-gu Korea, Republic of 561-712
    3 Chonnam National University Hospital Guangju Dong-gu Korea, Republic of 501-757
    4 Wonju Severance Christian Hospital Wonju Ilsan-ro Korea, Republic of 220-701
    5 Chungnam National University Hospital Daejeon Jung-gu Korea, Republic of 301-721
    6 Wonkwang University School of Medicine & Hospital Iksan Muwang-ro Korea, Republic of 570-711
    7 Yeungnam University Medical Center Daegu Nam-gu Korea, Republic of 705-703
    8 Kosin University Gospel Hospital Busan Seo-gu Korea, Republic of 602-702
    9 Dong-A University Hospital Busan Seo-gu Korea, Republic of 602-812
    10 Hanyang University Medical Center Seoul Seongdong-gu Korea, Republic of 133-792

    Sponsors and Collaborators

    • Chong Kun Dang Pharmaceutical

    Investigators

    • Principal Investigator: Sangyong Seol, Professor, Inje University Busanpaik Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chong Kun Dang Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT02356679
    Other Study ID Numbers:
    • EUPASIDIN-S_P4
    First Posted:
    Feb 5, 2015
    Last Update Posted:
    Aug 24, 2015
    Last Verified:
    Aug 1, 2015
    Additional relevant MeSH terms:
    Gastritis
    Ethanol

    Study Results

    No Results Posted as of Aug 24, 2015