ClinicalTrials.gg
Not yet recruitingNCT07631065Updated Jun 5, 2026

Phase 4 Study of Sto M Tab. in Acute or Chronic Gastritis

A Phase 4 interventional study of Stillen Tab. and Sto M Tab. in Gastritis, Acute Gastritis and Chronic Gastritis, sponsored by Mather's Pharm. Co., Ltd.. Not yet recruiting. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by Mather's Pharm. Co., Ltd. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
470
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Gastritis
  • Acute Gastritis
  • Chronic Gastritis

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03

In context

Gastritis

135 studies on the registry are indexed under Gastritis; 23 are open to participants now.

This study's planned enrollment of 470 is above the median of 200 across 97 interventional studies indexed under Gastritis.

Browse Gastritis studies →

Lead sponsor

Mather's Pharm. Co., Ltd. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female adults aged 19 to 75 years at the time of screening.
  2. 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.
  3. Female participants of or male participants who agree to maintain sexual abstinence or use appropriate methods during the study period and for 2 weeks after the last administration of the product. Periodic abstinence, such as calendar, ovulation, symptothermal, or post-ovulation methods, is not considered an acceptable contraceptive method.
  4. Participants who voluntarily provide written to participate in this clinical trial.

Exclusion criteria

Exclusion Criteria:

  1. 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 lesions. Participants with ulcer scars may be enrolled.
  2. Participants who have a history of gastric acid secretion-inhibiting surgery or gastric or esophageal surgery at screening (Visit 1).
  3. Participants who have been diagnosed with or have a history of Zollinger-Ellison syndrome at screening (Visit 1).
  4. 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).
  5. Participants with a history of 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.
  6. Participants with current or prior thrombotic disease at screening (Visit 1), such as cerebral thrombosis, myocardial infarction, thrombophlebitis, or venous thrombosis.
  7. Participants diagnosed with disseminated intravascular coagulation at screening (Visit 1).
  8. Participants with concomitant hepatic, renal, cardiac, pulmonary, hematologic, or other diseases that, in the investigator's judgment, may affect the efficacy or safety evaluations.
  9. 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.
  10. Participants with hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  11. Participants with a history of to soybean, peanut, or soybean oil.
  12. Participants with a history of hypersensitivity to any component of the products, such as tartrazine.
  13. Participants with clinically significant psychiatric disease at screening (Visit 1).
  14. Participants who meet any other exclusion criteria related to prior or concomitant medications specified in the protocol.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
470 participants (estimated)

Study arms

  • Experimental
    Sto M Tab. Group

    Drug: Sto M Tab.

  • Active comparator
    Stillen Tab. Group

    Drug: Stillen Tab.

Interventions

  • DrugStillen Tab.

    Stillen Tab., oral, three times daily, 2 weeks

  • DrugSto M Tab.

    Sto M Tab., oral, three times daiy, 2 weeks

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and Week 2

Secondary outcomes

  1. 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.

    Time frame: Baseline and Week 2

  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.

    Time frame: Week 2

  3. 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.

    Time frame: Week 2

  4. 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.

    Time frame: Baseline and Week 2

  5. 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.

    Time frame: Baseline and Week 2

  6. 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.

    Time frame: Baseline and Week 2

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Feb 2028, 20 months later.

Of 14 phase 4 interventional studies under Gastritis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 14. This study's planned 20 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 1, 2026
First posted
Jun 5, 2026
StartEst.
Jun 2026
Primary completionEst.
Feb 2028
CompletionEst.
Feb 2028
Last update
Jun 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07631065
Lead sponsor
Mather's Pharm. Co., Ltd.
Responsible party
Sponsor
First posted
Jun 5, 2026
Start date
Jun 2026 (estimated)
Primary completion
Feb 2028 (estimated)
Completion
Feb 2028 (estimated)
Last update
Jun 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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