Acute GastritisPhase 2NCT07139886
A Study to Evaluate the Safety and Efficacy of DA9601 for Acute and Chronic Gastritis and to Determine the Optimal Clinical Dosage and Administration
A Phase 2 study testing Stillen® Tab in people with Acute Gastritis and Chronic Gastritis, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This is a multicenter, placebo-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy of 2-week treatment with DA-9601 tab in patients with acute or chronic gastritis. Subject will receive DA-9601 180mg, 360mg tab or Placebo., three times a day for two weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Gastritis, Chronic Gastritis
- What is being tested?
- Stillen® Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Mar 1997to 8 Jul 1999
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are diagnosed with acute gastritis and chronic gastritis by endoscopy; have gastric mucosal lesions such as erosion, bleeding, redness, swelling on the site; and have subjective and objective symptoms requiring medical treatment ② 18 years old or older, 75 years old or younger ③ Patients who have agreed with the terms of clinical trials
Who cannot join
- Patients with peptic ulcer (excluding scars) and reflux esophagitis
- Patients who were administered with H2 antagonist, muscarine receptor antagonist or nonsteroidal anti-inflammatory drug within 2 weeks prior to the start of the trial
- Patients using protective agent enhancers at the start of the trial ④ Patients with recurrence observed during maintenance therapy at the start of the trial
- Patients with a history of gastrectomy
- Patients with severe disorders of the liver, kidneys, heart, lungs, blood, etc. ⑦ Patients with duodenal ulcer ⑧ Patients with gastrointestinal malignancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou University Medical Center, Division of Gastroenterology
Suwon, Gyeonggi-do, 16499
About this study
Official title: Phase 2b Multi-center Clinical Trials to Clarify the Efficacy and Adaptation Target of DA9601 in Patients With Acute and Chronic Gastritis, and to Determine the Optimal Clinical Dosage and Administration.
This is a multicenter, placebo-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy of 2-week treatment with DA-9601 tab in patients with acute or chronic gastritis. Subject will receive DA-9601 180mg, 360mg tab or Placebo., three times a day for two weeks.
- Conditions
- Acute Gastritis, Chronic Gastritis
- Being tested
- Stillen® Tab, Stillen® Tab Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stillen® TabDrug
Oral administration 3 times per day (in-between meals and before sleep) for 2 weeks
Stillen® Tab PlaceboDrug
Oral administration 3 times per day (in-between meals and before sleep) for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | administered 2 tablets of placebo three times daily for two weeks Receives: Drug: Stillen® Tab Placebo |
| DA-9601(Stillen®) 180mg | Experimental | administered 1 tablet of placebo and 1 tablet of DA-9601(Stillen®) three times daily for two weeks Receives: Drug: Stillen® Tab; Drug: Stillen® Tab Placebo |
| DA-9601(Stillen®) 360mg | Experimental | administered 2 tablets of DA-9601(Stillen®) three times daily for two weeks Receives: Drug: Stillen® Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Subjective and Objective Symptoms, Gastroscopy, Overall Improvement, Effectiveness grade
evaluated in 5 levels of "Significant improvement • Moderate improvement • Mild improvement • No improvement • Exacerbation"
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start14 Mar 1997
- Primary completion8 Jul 1999
- Study completion8 Jul 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GastritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 212 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
- NCT07139886
- Sponsor's protocol ID
- DA9601_GAS_IIb
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2b Multi-center Clinical Trials to Clarify the Efficacy and Adaptation Target of DA9601 in Patients With Acute and Chronic Gastritis, and to Determine the Optimal Clinical Dosage and Administration.
- ClinicalTrials.gov ID
- NCT07139886
- Acronym / sponsor ID
- DA9601_GAS_IIb
- Conditions
- Acute Gastritis, Chronic Gastritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 1997 (actual)
- Primary completion
- 8 Jul 1999 (actual)
- Study completion
- 8 Jul 1999 (actual)
- First posted
- 24 Aug 2025 (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 is a multicenter, placebo-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy of 2-week treatment with DA-9601 tab in patients with acute or chronic gastritis. Subject will receive DA-9601 180mg, 360mg tab or Placebo., three times a day for two weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Stillen® Tab Placeboadministered 2 tablets of placebo three times daily for two weeks |
| DA-9601(Stillen®) 180mg | Experimental | Drug: Stillen® Tab, Drug: Stillen® Tab Placeboadministered 1 tablet of placebo and 1 tablet of DA-9601(Stillen®) three times daily for two weeks |
| DA-9601(Stillen®) 360mg | Experimental | Drug: Stillen® Tabadministered 2 tablets of DA-9601(Stillen®) three times daily for two weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are diagnosed with acute gastritis and chronic gastritis by endoscopy; have gastric mucosal lesions such as erosion, bleeding, redness, swelling on the site; and have subjective and objective symptoms requiring medical treatment ② 18 years old or older, 75 years old or younger ③ Patients who have agreed with the terms of clinical trials
Key exclusion criteria (5 listed)
- Patients with peptic ulcer (excluding scars) and reflux esophagitis
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 |
|---|---|---|
| Stillen® TabOral administration 3 times per day (in-between meals and before sleep) for 2 weeks | Drug | DA-9601(Stillen®) 180mg, DA-9601(Stillen®) 360mg |
| Stillen® Tab PlaceboOral administration 3 times per day (in-between meals and before sleep) for 2 weeks | Drug | DA-9601(Stillen®) 180mg, Placebo |
Primary outcome
Change in Subjective and Objective Symptoms, Gastroscopy, Overall Improvement, Effectiveness grade
Time frame: 2 weeks
evaluated in 5 levels of "Significant improvement • Moderate improvement • Mild improvement • No improvement • Exacerbation"
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 29 Aug 2025.
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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 2 study testing Stillen® Tab in people with Acute Gastritis and Chronic Gastritis, 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?
The sponsor lists 1 inclusion and 5 exclusion criteria. 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 29 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in Subjective and Objective Symptoms, Gastroscopy, Overall Improvement, Effectiveness grade (time frame: 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 29 Aug 2025.