Efficacy and Safety of Eupasidin-s Tab.(EUPASIDIN-S) in Gastritis Patients
NCT ID: NCT02356679
Last Updated: 2015-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
230 participants
INTERVENTIONAL
2014-08-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stillen tab.
three times per day, 1 tab for each time, PO, during 2weeks
Stillen Tab.
three times per day, 1 tab for each time, PO, during 2weeks
Eupasidin-s tab.
three times per day, 1 tab for each time, PO, during 2weeks
Eupasidin-s Tab
three times per day, 1 tab for each time, PO, during 2weeks
Interventions
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Eupasidin-s Tab
three times per day, 1 tab for each time, PO, during 2weeks
Stillen Tab.
three times per day, 1 tab for each time, PO, during 2weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Sangyong Seol, Professor
Role: PRINCIPAL_INVESTIGATOR
Inje University Busanpaik Hospital
Locations
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Inje University Busanpaik hospital
Busan, Busangjin, South Korea
Chonbuk National University Hospital
Jeonju, Deokjin-gu, South Korea
Chonnam National University Hospital
Guangju, Dong-gu, South Korea
Wonju Severance Christian Hospital
Wŏnju, Ilsan-ro, South Korea
Chungnam National University Hospital
Daejeon, Jung-gu, South Korea
Wonkwang University School of Medicine & Hospital
Iksan, Muwang-ro, South Korea
Yeungnam University Medical Center
Daegu, Nam-gu, South Korea
Kosin University Gospel Hospital
Busan, Seo-gu, South Korea
Dong-A University Hospital
Busan, Seo-gu, South Korea
Hanyang University Medical Center
Seoul, Seongdong-gu, South Korea
Countries
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Other Identifiers
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EUPASIDIN-S_P4
Identifier Type: -
Identifier Source: org_study_id
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