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

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
This Phase 4 clinical trial will assess the efficacy and safety of Stoem Tab. compared toStillen Tab. in adults with acute or chronic gastritis. Participants will be randomizedin a double‐blind, parallel, active‐controlled design to receive either Stoem Tab. orStillen Tab. for 2 weeks. The primary endpoint is the effective rate of gastric mucosalerosion at Week 2, assessed by upper gastrointestinal endoscopy and evaluated by anindependent reviewer. A responder is defined as a participant whose erosion score at Week2 has improved by at least 50% compared to baseline (i.e., a decrease from grade 4 tograde 2 or 1, or from grade 3 or 2 to grade 1). The effective rate is calculated as theproportion of responders among the evaluable participants. Secondary endpoints includeadditional efficacy and safety evaluations. The study aims to demonstrate thenon‐inferiority of Stoem Tab. to Stillen Tab. All participants will be monitored forefficacy, safety, and medication compliance, and standard eligibility criteria will beapplied.
Epistemonikos ID: 9ca85ed7a8645b4167ba04f9a71e317f2066a0a7
First added on: Jun 06, 2026