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

August 21, 2015 updated by: Chong Kun Dang Pharmaceutical

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Busangjin
      • Busan, Busangjin, Korea, Republic of, 614-735
        • Inje University Busanpaik Hospital
    • Deokjin-gu
      • Jeonju, Deokjin-gu, Korea, Republic of, 561-712
        • Chonbuk National University Hospital
    • Dong-gu
      • Guangju, Dong-gu, Korea, Republic of, 501-757
        • Chonnam National University Hospital
    • Ilsan-ro
      • Wonju, Ilsan-ro, Korea, Republic of, 220-701
        • WonJu Severance Christian Hospital
    • Jung-gu
      • Daejeon, Jung-gu, Korea, Republic of, 301-721
        • Chungnam National University Hospital
    • Muwang-ro
      • Iksan, Muwang-ro, Korea, Republic of, 570-711
        • Wonkwang University School of Medicine & Hospital
    • Nam-gu
      • Daegu, Nam-gu, Korea, Republic of, 705-703
        • Yeungnam University Medical Center
    • Seo-gu
      • Busan, Seo-gu, Korea, Republic of, 602-702
        • Kosin University Gospel Hospital
      • Busan, Seo-gu, Korea, Republic of, 602-812
        • Dong-A University Hospital
    • Seongdong-gu
      • Seoul, Seongdong-gu, Korea, Republic of, 133-792
        • Hanyang University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cure rate of erosion
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
improvement rate of erosion
Time Frame: 2 weeks
2 weeks
improvement rate of erythema
Time Frame: 2 weeks
2 weeks
improvement rate of hemorrhage
Time Frame: 2 weeks
2 weeks
improvement rate of edema
Time Frame: 2 weeks
2 weeks
improvement rate of self symptoms
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 2, 2014

First Submitted That Met QC Criteria

February 4, 2015

First Posted (Estimate)

February 5, 2015

Study Record Updates

Last Update Posted (Estimate)

August 24, 2015

Last Update Submitted That Met QC Criteria

August 21, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUPASIDIN-S_P4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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