Study to Assess the Efficacy and Safety of SK-MS10 in Subjects With Acute and Chronic Gastritis

Phase 2CompletedNCT01578811

SK Chemicals Co., Ltd.102 enrolled

Overview

The purpose of this study is to Assess the Efficacy and Safety of SK-MS10 in subjects With acute and chronic gastritis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

102

Conditions

Erosive Gastritis

Interventions

PlaceboDRUG

Dosage

SK-MS10DRUG

Dosage

SK-MS10DRUG

Dosage

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Have been diagnosed as erosive gastritis by endoscopy within 1 weeks before enrollment. 2. Patients who voluntarily signed written informed consent may participate in the study. Exclusion Criteria: 1. Pregnant or lactating female. 2. Patients have gastric ulcer, duodenal ulcer and GERD. 3. Use of any proton pump inhibitor, H2-receptor antagonist, muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study drug therapy 4. Patients requiring corticosteroid therapy 5. Severe neurological or psychological disease 6. History of allergic reaction to the medications used in this study 7. Use of other investigational drugs within 30 days prior to the study. 8. Patients that investigators consider ineligible for this study

Locations (1)

SKChemicals

Seoul, South Korea

Outcomes

Primary Outcomes

Improvement rates of erosive gastritis according to the sydney classification

Time frame: Change from Baseline in the grade of erosive gastritis at 2 weeks

Secondary Outcomes

Healing rates of erosive gastritis according to the sydney classification

Time frame: Change from Baseline in the grade of gastric erosions at 2 weeks

Improvement rates of erosive gastritis by estimated the number of erosion

Time frame: Change from Baseline in the number of gastric erosions at 2 weeks

Healing rates of edema according to the sydney classification

Time frame: Change from Baseline in the grade of edema at 2 weeks

Improvement rates of erythema according to the sydney classification

Time frame: Change from Baseline in the grade of erythema at 2 weeks

Improvement rates of hemorrhage according to the Scandinavian Journal of Gastroenterology - Supplement

Time frame: Change from Baseline in the grade of hemorrhage at 2 weeks

Improvement rates of symptoms using Korean NDI

Time frame: Questionaire at baseline and then week 2

Data from ClinicalTrials.gov

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