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

NCT ID: NCT06151210

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

467 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2025-07-15

Brief Summary

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

Detailed Description

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Conditions

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Gastritis Acute Gastritis Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DA-5219

administered for 2weeks(DA-5219 + Stillen® Tab placebo)

Group Type EXPERIMENTAL

DA-5219

Intervention Type DRUG

1 tablet/day

Stillen® Tab Placebo

Intervention Type DRUG

3 tablets/day

Stillen® Tab

administered for 2weeks(Stillen® Tab + DA-5219 placebo)

Group Type ACTIVE_COMPARATOR

Stillen® Tab

Intervention Type DRUG

3 tablets/day

DA-5219 Placebo

Intervention Type DRUG

1 tablet/day

Interventions

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DA-5219

1 tablet/day

Intervention Type DRUG

Stillen® Tab

3 tablets/day

Intervention Type DRUG

DA-5219 Placebo

1 tablet/day

Intervention Type DRUG

Stillen® Tab Placebo

3 tablets/day

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DA5219_GAS_III

Identifier Type: -

Identifier Source: org_study_id

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