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

Chronic Gastritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356679
• Other study ID #: EUPASIDIN-S_P4
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2014
• Last updated: August 21, 2015
• Start date: August 2014
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Gastritis
• Chronic Gastritis
• Gastritis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan	Seo-gu
Korea, Republic of	Inje University Busanpaik hospital	Busan	Busangjin
Korea, Republic of	Kosin University Gospel Hospital	Busan	Seo-gu
Korea, Republic of	Yeungnam University Medical Center	Daegu	Nam-gu
Korea, Republic of	Chungnam National University Hospital	Daejeon	Jung-gu
Korea, Republic of	Chonnam National University Hospital	Guangju	Dong-gu
Korea, Republic of	Wonkwang University School of Medicine & Hospital	Iksan	Muwang-ro
Korea, Republic of	Chonbuk National University Hospital	Jeonju	Deokjin-gu
Korea, Republic of	Hanyang University Medical Center	Seoul	Seongdong-gu
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Ilsan-ro

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cure rate of erosion		2 weeks	No
Secondary	improvement rate of erosion		2 weeks	No
Secondary	improvement rate of erythema		2 weeks	No
Secondary	improvement rate of hemorrhage		2 weeks	No
Secondary	improvement rate of edema		2 weeks	No
Secondary	improvement rate of self symptoms		2 weeks	No