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

Phase 2

• Conditions: Acute and Chronic Gastric Inflammation Patients
• Interventions: Drug: Placebo; Drug: DW-3101_150mg; Drug: DW-3101_300mg; Drug: DW-3101_600mg

• Registration Number: NCT02386007
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-16
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-11
• Last Update Posted: 2016-10-12
• Primary Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
a tablet same as experimental agents in formation and shape	Placebo	Placebo
DW-3101_150mg	DW-3101_150mg	150mg a day
DW-3101_300mg	DW-3101_300mg	300mg a day
DW-3101_600mg	DW-3101_600mg	600mg a day

Primary Outcome Measures

Name	Time	Method
The change of gastric erosion score	14day±3	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.