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

April 2, 2024 updated by: Dong-A ST Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

452

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DA-5219
administered for 2weeks(DA-5219 + Stillen® Tab placebo)
Drug: DA-5219
1 tablet/day
Drug: Stillen® Tab Placebo
3 tablets/day
Active Comparator: Stillen® Tab
administered for 2weeks(Stillen® Tab + DA-5219 placebo)
Drug: Stillen® Tab
3 tablets/day
Drug: DA-5219 Placebo
1 tablet/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement rate of gastric mucosal erosion
Time Frame: Change from baseline at 2 weeks
Change from baseline at 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Cure rate for gastric mucosal erosion
Time Frame: Change from baseline at 2 weeks
Change from baseline at 2 weeks
Cure rate for gastric mucosal edema
Time Frame: Change from baseline at 2 weeks
Change from baseline at 2 weeks
Improvement rate for gastric mucosal erythema
Time Frame: Change from baseline at 2 weeks
Change from baseline at 2 weeks
Improvement rate for gastric mucosal bleeding
Time Frame: Change from baseline at 2 weeks
Change from baseline at 2 weeks
Improvement rate for gastric subjective symptoms
Time Frame: Change from baseline at 2 weeks
Change from baseline at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 30, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA5219_GAS_III

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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