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Completed

NCT Number: NCT06151210

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

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

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Key information

Conditions

Gastritis Acute Gastritis Chronic

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main 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

Treatment and study plan

DA-5219

Drug

1 tablet/day

Stillen® Tab

Drug

3 tablets/day

DA-5219 Placebo

Drug

1 tablet/day

Stillen® Tab Placebo

Drug

3 tablets/day

Primary outcomes

  1. Improvement rate of gastric mucosal erosion

    Time frame: Change from baseline at 2 weeks

Secondary outcomes

  1. Cure rate for gastric mucosal erosion

    Time frame: Change from baseline at 2 weeks

  2. Cure rate for gastric mucosal edema

    Time frame: Change from baseline at 2 weeks

  3. Improvement rate for gastric mucosal erythema

    Time frame: Change from baseline at 2 weeks

  4. Improvement rate for gastric mucosal bleeding

    Time frame: Change from baseline at 2 weeks

  5. Improvement rate for gastric subjective symptoms

    Time frame: Change from baseline at 2 weeks

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-5219 in Patients With Acute or Chronic Gastritis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 30, 2023
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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