GastritisPhase 4NCT07631065
Phase 4 Study of Sto M Tab. in Acute or Chronic Gastritis
A Phase 4 study testing Stillen Tab. and Sto M Tab. in people with Gastritis and Acute Gastritis, run by Mather's Pharm. Co., Ltd..
Trial summary
This Phase 4, multicenter, randomized, double-blind, active-controlled, non-inferiority study aims to evaluate the non-inferiority of Stoem Tab. compared to Stillen Tab. (Dong-A ST Co., Ltd.) in patients with acute or chronic gastritis. Participants will receive either Stoem Tab. or Stillen Tab. for 2 weeks. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Gastritis, Acute Gastritis, Chronic Gastritis
- What is being tested?
- Stillen Tab. and Sto M Tab.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Feb 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Male or female adults aged 19 to 75 years at the time of screening.
- Participants diagnosed with acute or chronic gastritis by upper gastrointestinal endoscopy performed within 7 days prior to randomization (Visit 2), with at least one gastric erosion confirmed. Erosions of the esophagus and duodenum are excluded.
- Female participants of childbearing potential or male participants who agree to maintain sexual abstinence or use appropriate contraceptive methods during the study period and for 2 weeks after the last administration of the investigational product. Periodic abstinence, such as calendar, ovulation, symptothermal, or post-ovulation methods, is not considered an acceptable contraceptive method.
- Participants who voluntarily provide written informed consent to participate in this clinical trial.
Who cannot join
- Participants with any of the following lesions confirmed or accompanied by upper gastrointestinal endoscopy at screening (Visit 1): active or healing peptic ulcer; reflux esophagitis; Barrett's esophagus greater than 3 cm; gastroesophageal varices; esophageal stricture; or other clinically relevant lesions. Participants with ulcer scars may be enrolled.
- Participants who have a history of gastric acid secretion-inhibiting surgery or gastric or esophageal surgery at screening (Visit 1).
- Participants who have been diagnosed with or have a history of Zollinger-Ellison syndrome at screening (Visit 1).
- Participants with inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or intestinal Behcet's disease; primary esophageal motility disorder; or pancreatitis at screening (Visit 1).
- Participants with a history of malignancy within 5 years prior to screening (Visit 1). However, participants who have been completely treated and have had no recurrence for at least 5 years may be enrolled at the investigator's discretion. Participants with gastrointestinal malignancy are excluded regardless of the time since diagnosis. Participants with basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, or carcinoma in situ of other sites may be enrolled at the investigator's discretion if they have been completely treated and have had no recurrence for at least 3 years.
- Participants with current or prior thrombotic disease at screening (Visit 1), such as cerebral thrombosis, myocardial infarction, thrombophlebitis, or venous thrombosis.
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- Participants diagnosed with disseminated intravascular coagulation at screening (Visit 1).
- Participants with concomitant hepatic, renal, cardiac, pulmonary, hematologic, or other diseases that, in the investigator's judgment, may affect the efficacy or safety evaluations.
- Participants with current or prior lipid metabolism disorders at screening (Visit 1), such as hyperlipidemia or diabetic hyperlipidemia, or participants who require cautious administration of lipid nutritional products. However, participants whose condition is adequately controlled with medication may be enrolled at the investigator's discretion.
- Participants with hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Participants with a history of hypersensitivity to soybean, peanut, or soybean oil.
- Participants with a history of hypersensitivity to any component of the investigational products, such as tartrazine.
- Participants with clinically significant psychiatric disease at screening (Visit 1).
- Participants who meet any other exclusion criteria related to prior or concomitant medications specified in the protocol.
About this study
Official title: A Randomized, Double-blinded, Active Controlled, Non-Inferiority, Multicenter, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Sto M Tab. in Patients With Acute or Chronic Gastritis
This Phase 4, multicenter, randomized, double-blind, active-controlled, non-inferiority study aims to evaluate the non-inferiority of Stoem Tab. compared to Stillen Tab. (Dong-A ST Co., Ltd.) in patients with acute or chronic gastritis. Participants will receive either Stoem Tab. or Stillen Tab. for 2 weeks. The primary outcome is the effective rate of gastric mucosal erosion at Week 2, assessed by upper gastrointestinal endoscopy and evaluated by an independent reviewer, defined as the proportion of participants achieving at least a 50% improvement in erosion score compared to baseline.
Read the detailed description
This Phase 4 clinical trial will assess the efficacy and safety of Stoem Tab. compared to Stillen Tab. in adults with acute or chronic gastritis. Participants will be randomized in a double-blind, parallel, active-controlled design to receive either Stoem Tab. or Stillen Tab. for 2 weeks. The primary endpoint is the effective rate of gastric mucosal erosion at Week 2, assessed by upper gastrointestinal endoscopy and evaluated by an independent reviewer. A responder is defined as a participant whose erosion score at Week 2 has improved by at least 50% compared to baseline (i.e., a decrease from grade 4 to grade 2 or 1, or from grade 3 or 2 to grade 1). The effective rate is calculated as the proportion of responders among the evaluable participants. Secondary endpoints include additional efficacy and safety evaluations. The study aims to demonstrate the non-inferiority of Stoem Tab. to Stillen Tab. All participants will be monitored for efficacy, safety, and medication compliance, and standard eligibility criteria will be applied.
- Conditions
- Gastritis, Acute Gastritis, Chronic Gastritis
- Being tested
- Stillen Tab., Sto M Tab.
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stillen Tab.Drug
Stillen Tab., oral, three times daily, 2 weeks
Sto M Tab.Drug
Sto M Tab., oral, three times daiy, 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sto M Tab. Group | Experimental | Not described Receives: Drug: Sto M Tab. |
| Stillen Tab. Group | Active comparator | Not described Receives: Drug: Stillen Tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Rate of Gastric Mucosal Erosion Assessed by an Independent Reviewer
Proportion of participants whose erosion score improved by at least 50% from baseline to Week 2, as assessed by upper gastrointestinal endoscopy and evaluated by an independent reviewer.
Measured: Baseline and Week 2
Secondary outcomes (6)
Effective Rate of Gastric Mucosal Erosion Assessed by the Investigator
Proportion of participants whose erosion score improved by at least 50% from baseline to Week 2, as assessed by upper gastrointestinal endoscopy.
Measured: Baseline and Week 2
Complete Cure Rate of Gastric Mucosal Erosion Assessed by the Investigator
Proportion of participants with complete resolution of gastric mucosal erosion at Week 2, as assessed by upper gastrointestinal endoscopy.
Measured: Week 2
Complete Cure Rate of Gastric Mucosal Edema Assessed by the Investigator
Proportion of participants with complete resolution of gastric mucosal edema at Week 2, as assessed by upper gastrointestinal endoscopy.
Measured: Week 2
Effective Rate of Gastric Mucosal Redness Assessed by the Investigator
Proportion of participants whose redness score improved by at least 50% from baseline to Week 2, as assessed by upper gastrointestinal endoscopy.
Measured: Baseline and Week 2
Effective Rate of Gastric Mucosal Hemorrhage Assessed by the Investigator
Proportion of participants whose hemorrhage score improved by at least 50% from baseline to Week 2, as assessed by upper gastrointestinal endoscopy.
Measured: Baseline and Week 2
Improvement Rate of Subjective Symptom Score Assessed by the Investigator
Proportion of participants whose total subjective symptom score improved by at least 50% from baseline to Week 2, as assessed by a self-reported questionnaire.
Measured: Baseline and Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mather's Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631065
- Sponsor's protocol ID
- MTS-STO-401
- Status last verified
- May 2026
- First submitted
- 1 Jun 2026
- Last updated
- 5 Jun 2026
- 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Active Controlled, Non-Inferiority, Multicenter, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Sto M Tab. in Patients With Acute or Chronic Gastritis
- ClinicalTrials.gov ID
- NCT07631065
- Acronym / sponsor ID
- MTS-STO-401
- Conditions
- Gastritis, Acute Gastritis, Chronic Gastritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Mather's Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 5 Jun 2026 (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 Phase 4, multicenter, randomized, double-blind, active-controlled, non-inferiority study aims to evaluate the non-inferiority of Stoem Tab. compared to Stillen Tab. (Dong-A ST Co., Ltd.) in patients with acute or chronic gastritis. Participants will receive either Stoem Tab. or Stillen Tab. for 2 weeks. The primary outcome is the effective rate of gastric mucosal erosion at Week 2, assessed by upper gastrointestinal endoscopy and evaluated by an independent reviewer, defined as the proportion of participants achieving at least a 50% improvement in erosion score compared to baseline.
Detailed description
This Phase 4 clinical trial will assess the efficacy and safety of Stoem Tab. compared to Stillen Tab. in adults with acute or chronic gastritis. Participants will be randomized in a double-blind, parallel, active-controlled design to receive either Stoem Tab. or Stillen Tab. for 2 weeks. The primary endpoint is the effective rate of gastric mucosal erosion at Week 2, assessed by upper gastrointestinal endoscopy and evaluated by an independent reviewer. A responder is defined as a participant whose erosion score at Week 2 has improved by at least 50% compared to baseline (i.e., a decrease from grade 4 to grade 2 or 1, or from grade 3 or 2 to grade 1). The effective rate is calculated as the proportion of responders among the evaluable participants. Secondary endpoints include additional efficacy and safety evaluations. The study aims to demonstrate the non-inferiority of Stoem Tab. to Stillen Tab. All participants will be monitored for efficacy, safety, and medication compliance, and standard eligibility criteria will be applied.
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 |
|---|---|---|
| Sto M Tab. Group | Experimental | Drug: Sto M Tab. |
| Stillen Tab. Group | Active comparator | Drug: Stillen Tab. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female adults aged 19 to 75 years at the time of screening.
- Participants diagnosed with acute or chronic gastritis by upper gastrointestinal endoscopy performed within 7 days prior to randomization (Visit 2), with at least one gastric erosion confirmed. Erosions of the esophagus and duodenum are excluded.
- Female participants of childbearing potential or male participants who agree to maintain sexual abstinence or use appropriate contraceptive methods during the study period and for 2 weeks after the last administration of the investigational product. Periodic abstinence, such as calendar, ovulation, symptothermal, or post-ovulation methods, is not considered an acceptable contraceptive method.
- Participants who voluntarily provide written informed consent to participate in this clinical trial.
Key exclusion criteria (14 listed)
- Participants with any of the following lesions confirmed or accompanied by upper gastrointestinal endoscopy at screening (Visit 1): active or healing peptic ulcer; reflux esophagitis; Barrett's esophagus greater than 3 cm; gastroesophageal varices; esophageal stricture; or other clinically relevant lesions. Participants with ulcer scars may be enrolled.
- Participants who have a history of gastric acid secretion-inhibiting surgery or gastric or esophageal surgery at screening (Visit 1).
- Participants who have been diagnosed with or have a history of Zollinger-Ellison syndrome at screening (Visit 1).
- Participants with inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or intestinal Behcet's disease; primary esophageal motility disorder; or pancreatitis at screening (Visit 1).
- Participants with a history of malignancy within 5 years prior to screening (Visit 1). However, participants who have been completely treated and have had no recurrence for at least 5 years may be enrolled at the investigator's discretion. Participants with gastrointestinal malignancy are excluded regardless of the time since diagnosis. Participants with basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, or carcinoma in situ of other sites may be enrolled at the investigator's discretion if they have been completely treated and have had no recurrence for at least 3 years.
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 Tab.Stillen Tab., oral, three times daily, 2 weeks | Drug | Stillen Tab. Group |
| Sto M Tab.Sto M Tab., oral, three times daiy, 2 weeks | Drug | Sto M Tab. Group |
Primary outcome
Effective Rate of Gastric Mucosal Erosion Assessed by an Independent Reviewer
Time frame: Baseline and Week 2
Proportion of participants whose erosion score improved by at least 50% from baseline to Week 2, as assessed by upper gastrointestinal endoscopy and evaluated by an independent reviewer.
6 secondary outcomes
Effective Rate of Gastric Mucosal Erosion Assessed by the Investigator
Time frame: Baseline and Week 2
Complete Cure Rate of Gastric Mucosal Erosion Assessed by the Investigator
Time frame: Week 2
Complete Cure Rate of Gastric Mucosal Edema Assessed by the Investigator
Time frame: Week 2
Effective Rate of Gastric Mucosal Redness Assessed by the Investigator
Time frame: Baseline and Week 2
Effective Rate of Gastric Mucosal Hemorrhage Assessed by the Investigator
Time frame: Baseline and Week 2
Improvement Rate of Subjective Symptom Score Assessed by the Investigator
Time frame: Baseline and Week 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stillen Tab. and Sto M Tab. in people with Gastritis and Acute Gastritis, run by Mather's Pharm. Co., Ltd..
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 4 inclusion and 14 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: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Effective Rate of Gastric Mucosal Erosion Assessed by an Independent Reviewer (time frame: Baseline and Week 2). 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 5 Jun 2026.