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

NCT07631065 | Not Yet Recruiting Phase 4

• 1 other identifier: MTS-STO-401
• Study Type: interventional
• Target: 470
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Gastritis; Gastritis; Acute Gastritis

Outcome Measures

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.

  Baseline and Week 2

Secondary Outcomes (6)

• Effective Rate of Gastric Mucosal Erosion Assessed by the Investigator

  Baseline and Week 2

• Complete Cure Rate of Gastric Mucosal Erosion Assessed by the Investigator

  Week 2

• Complete Cure Rate of Gastric Mucosal Edema Assessed by the Investigator

  Week 2

• Effective Rate of Gastric Mucosal Redness Assessed by the Investigator

  Baseline and Week 2

• Effective Rate of Gastric Mucosal Hemorrhage Assessed by the Investigator

  Baseline and Week 2

Study Arms (2)

Sto M Tab. Group

EXPERIMENTAL

Drug: Sto M Tab.

Stillen Tab. Group

ACTIVE COMPARATOR

Drug: Stillen Tab.

Interventions

Stillen Tab. DRUG

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

Stillen Tab. Group

Sto M Tab. DRUG

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

Sto M Tab. Group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Mather's Pharm. Co., Ltd.: lead

MeSH Terms

Conditions

Gastritis

Interventions

DA 9601

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-05