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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sto M Tab. Group | Experimental |
| |
| Stillen Tab. Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stillen Tab. | Drug | Stillen Tab., oral, three times daily, 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 2 |
| Complete Cure Rate of Gastric Mucosal Erosion Assessed by the Investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D005756 | Gastritis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C116959 | DA 9601 |
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| Sto M Tab. |
| Drug |
Sto M Tab., oral, three times daiy, 2 weeks |
|
Proportion of participants with complete resolution of gastric mucosal erosion at Week 2, as assessed by upper gastrointestinal endoscopy. |
| 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. | 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. | 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. | 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. | Baseline and Week 2 |