Phase 2a Study to Evaluate Optimum Dosage and Stability of DW-3101 in Gastric Inflammation Patients

Daewon Pharmaceutical Co., Ltd.60 enrolled

Overview

The purpose of this study is to find optimum dosage of DW-3101 by evaluating efficacy and safety of each dosage group in Korean patients with acute and chronic gastric inflammation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Acute and Chronic Gastric Inflammation Patients

Interventions

DW-3101_150mgDRUG

DW-3101_300mgDRUG

DW-3101_600mgDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult males/females aged 20\~75 years * Patients detected over 1 erosion who diagnosed as acute or chronic gastric inflammation by gastrscopy in 7days before administration of experimental agents * Subjects who voluntarily agree to participate in this clinical test with written consent Exclusion Criteria: * Patients impossible gastroscopy * In case accompanied with gastric ulcer(scar excepted) or reflux esophagitis * Patients who had stomach or esophagus surgery to inhibit gastric acid secretion (tresis or appendicectomy surgery excluded) * Patients with malignant tumor on digestive organ * Patients with blood clot(cerebral thrombosis, myocardial infarction, septic thrombophlebitis) and who have antithrombotic agents (eg. warfarin)

Outcomes

Primary Outcomes

The change of gastric erosion score

The erosion score is evaluated by gastroscopy. Erosion score The number of erosion 1. 0 2. 1\~2 3. 3\~5 4. More than 6 If patient's erosion score is decreased by 50% compared with erosion score before clinical dosing, we count it as effectiveness.

Time frame: 14day±3

Data from ClinicalTrials.gov

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