Gastritis AcutePhase 3NCT06151210
Clinical Trial to Evaluate the Efficacy and Safety of DA-5219 in Patients With Acute or Chronic Gastritis
A Phase 3 study testing DA-5219 and Stillen® Tab in people with Gastritis Acute and Gastritis Chronic, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This study is to evaluate the efficacy and safety of DA-5219 in patients with acute or chronic gastritis Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Gastritis Acute, Gastritis Chronic
- What is being tested?
- DA-5219 and Stillen® Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 467 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Jan 2024to 15 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
This study is to evaluate the efficacy and safety of DA-5219 in patients with acute or chronic gastritis
- Conditions
- Gastritis Acute, Gastritis Chronic
- Being tested
- DA-5219, Stillen® Tab, DA-5219 Placebo, Stillen® Tab Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-5219Drug
1 tablet/day
Stillen® TabDrug
3 tablets/day
DA-5219 PlaceboDrug
1 tablet/day
Stillen® Tab PlaceboDrug
3 tablets/day
| Study group | Role | What they receive |
|---|---|---|
| DA-5219 | Experimental | administered for 2weeks(DA-5219 + Stillen® Tab placebo) Receives: Drug: DA-5219; Drug: Stillen® Tab Placebo |
| Stillen® Tab | Active comparator | administered for 2weeks(Stillen® Tab + DA-5219 placebo) Receives: Drug: Stillen® Tab; Drug: DA-5219 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rate of gastric mucosal erosion
Measured: Change from baseline at 2 weeks
Secondary outcomes (5)
Cure rate for gastric mucosal erosion
Measured: Change from baseline at 2 weeks
Cure rate for gastric mucosal edema
Measured: Change from baseline at 2 weeks
Improvement rate for gastric mucosal erythema
Measured: Change from baseline at 2 weeks
Improvement rate for gastric mucosal bleeding
Measured: Change from baseline at 2 weeks
Improvement rate for gastric subjective symptoms
Measured: Change from baseline at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start31 Jan 2024
- Primary completion10 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastritis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151210
- Sponsor's protocol ID
- DA5219_GAS_III
- Status last verified
- Aug 2025
- First submitted
- 21 Nov 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06151210
- Acronym / sponsor ID
- DA5219_GAS_III
- Conditions
- Gastritis Acute, Gastritis Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the efficacy and safety of DA-5219 in patients with acute or chronic gastritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-5219 | Experimental | Drug: DA-5219, Drug: Stillen® Tab Placeboadministered for 2weeks(DA-5219 + Stillen® Tab placebo) |
| Stillen® Tab | Active comparator | Drug: Stillen® Tab, Drug: DA-5219 Placeboadministered for 2weeks(Stillen® Tab + DA-5219 placebo) |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-52191 tablet/day | Drug | DA-5219 |
| Stillen® Tab3 tablets/day | Drug | Stillen® Tab |
| DA-5219 Placebo1 tablet/day | Drug | Stillen® Tab |
| Stillen® Tab Placebo3 tablets/day | Drug | DA-5219 |
Primary outcome
Improvement rate of gastric mucosal erosion
Time frame: Change from baseline at 2 weeks
5 secondary outcomes
Cure rate for gastric mucosal erosion
Time frame: Change from baseline at 2 weeks
Cure rate for gastric mucosal edema
Time frame: Change from baseline at 2 weeks
Improvement rate for gastric mucosal erythema
Time frame: Change from baseline at 2 weeks
Improvement rate for gastric mucosal bleeding
Time frame: Change from baseline at 2 weeks
Improvement rate for gastric subjective symptoms
Time frame: Change from baseline at 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DA-5219 and Stillen® Tab in people with Gastritis Acute and Gastritis Chronic, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement rate of gastric mucosal erosion (time frame: Change from baseline at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.