Clinical Trial to Evaluate the Efficacy and Safety of DA-5219 in Patients With Acute or Chronic Gastritis

Phase 3

Recruiting

• Conditions: Gastritis Chronic; Gastritis Acute
• Interventions: Drug: DA-5219; Drug: Stillen® Tab; Drug: Stillen® Tab Placebo; Drug: DA-5219 Placebo

• Registration Number: NCT06151210
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

This study is to evaluate the efficacy and safety of DA-5219 in patients with acute or chronic gastritis

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2023-11-21
• Study First Posted: 2023-11-30
• Study Start: 2024-01-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-04
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 452

Inclusion Criteria

• Men or women aged ≥ 19 years and ≤ 75 years
• Subjects who diagnosed with acute or chronic gastritis by upper gastrointestinal endoscopy within 7days prior to the randomization
• Subjects who have one or more erosions identified on upper gastrointestinal endoscopy within 7days prior to the randomization
• Subjects who voluntarily signed a consent form

Main

Exclusion Criteria

• Ineligible for upper gastrointestinal endoscopy
• Subjects with active or healing gastroduodenal ulcer, reflux esophagitis, Barrett's esophagus, or gastroesophageal varices identified on upper gastrointestinal endoscopy within 7days prior to the randomization
• Subjects with hypersensitivity to investigational drugs and similar drugs
• Pregnant or breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA-5219	DA-5219	administered for 2weeks(DA-5219 + Stillen® Tab placebo)
DA-5219	Stillen® Tab Placebo	administered for 2weeks(DA-5219 + Stillen® Tab placebo)
Stillen® Tab	Stillen® Tab	administered for 2weeks(Stillen® Tab + DA-5219 placebo)
Stillen® Tab	DA-5219 Placebo	administered for 2weeks(Stillen® Tab + DA-5219 placebo)

Primary Outcome Measures

Name	Time	Method
Improvement rate of gastric mucosal erosion	Change from baseline at 2 weeks

Secondary Outcome Measures

Name	Time	Method
Improvement rate for gastric subjective symptoms	Change from baseline at 2 weeks
Cure rate for gastric mucosal erosion	Change from baseline at 2 weeks
Improvement rate for gastric mucosal bleeding	Change from baseline at 2 weeks
Cure rate for gastric mucosal edema	Change from baseline at 2 weeks
Improvement rate for gastric mucosal erythema	Change from baseline at 2 weeks

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of