Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis

Daewoong Pharmaceutical Co. LTD.327 enrolled

Overview

The purpose of study is to confirm the efficacy of DWP14012 X mg QD, DWP14012 Y mg BID compared to placebo in patients with Acute or Chronic Gastritis

This study was designed as a multi-center, randomized, double-blind, placebo-controlled, parallel-group, phase 3 study to assess the efficacy and safety of oral administration of DWP14012 X mg QD, Y mg BID and placebo for 2 weeks in patients with acute and chronic gastritis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

327

Conditions

Acute Gastritis Chronic Gastritis

Interventions

DWP14012 X mgDRUG

DWP14012 X mg, tablet, orally, once daily for 2 weeks

DWP14012 X mg placeboDRUG

DWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks

DWP14012 Y mgDRUG

DWP14012 Y mg, tablet, orally, twice daily for 2 weeks

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults between 19 and 75 years old based on the date of written agreement * Those who are diagnosed with acute or chronic gastritis with at least one erosion observed on upper gastrointestinal endoscopy * Those who had experienced one or more subjective symptoms of gastritis Exclusion Criteria: * Those who have had surgery to reduce gastric acid secretion, or gastric or esophageal surgery * Those with history of clinically significant hepatic, renal, neurologic, pulmonary, endocrine, hematologic, cardiovascular or genitourinary disease that could affect the study results

Locations (1)

Hanyang University Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Improvement rate of gastric mucosal erosion

Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erosion score) / Number of target cases) x 100