drugset / Trial / NCT07631065

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

NCT07631065

Phase 4 Not yet recruiting 470 enrolled Mather's Pharm. Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-06
Primary completion
2028-02
Completion
2028-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Stillen Tab. Unknown Oral
Subject Sto M Tab. Unknown Oral

Indications