Ireland
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Starting soon Phase 3

Phase 3 to Evaluate the Efficacy and Safety of DWP14012 in Patients With Gastric Ulcer

NCT07730138 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 3
Started
2026-10-15
Last updated
2026-07-28

Condition(s) studied

Gastric Ulcer

Investigational drug(s) / intervention(s)

DWP14012 40mg (Fexuprazan) →Lansoprazole 30mg →

DWP14012 40mg (Fexuprazan): DWP14012 40mg(Fexuprazan) + placebo of Lansoprazole

Lansoprazole 30mg: Lansoprazole 30mg + Placebo of DWP14012 40mg

Study summary

A Multinational, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group, Phase 3 Study to Evaluate the Efficacy and Safety of DWP14012 in Participants with Gastric Ulcer

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. At least one gastric ulcer is present, and the largest gastric ulcer measures ≥ 3 mm and ≤ 30 mm in diameter 2. The Sakita-Miwa classification of the largest gastric ulcer is A1 or A2. Exclusion Criteria: 1. Participants with a history of Zollinger-Ellison syndrome or conditions associated with gastric hypersecretion. 2. Participants who, within 30 days prior to the screening visit (Visit 1), have undergone or are scheduled to undergo major surgery that may affect gastric acid secretion. 3. Participants with a history of malignancy within 5 years prior to the screening visit (Visit 1); gastrointestinal malignancies are excluded regardless of the time elapsed. 4. Participants who, at the screening visit (Visit 1), have gastrointestinal active bleeding , esophageal stricture, ulcer-induced stenosis, pyloric stenosis, gastroesophageal varices, Barrett's esophagus (\> 3 cm), esophageal dysplasia, duodenal ulcer, refractory ulcer, perforated ulcer, or surgery-induced ulcer 5. Participants who, at the screening visit (Visit 1), have pancreatitis or inflammatory bowel disease (including Crohn's disease, ulcerative colitis, or intestinal Behçet's disease).

Primary outcome measure(s)

  • Cumulative gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy through Week 8 — Week 8

Trial sites (2)

FacilityCityRegionStatus
RS Cipto Mangunkusumo Jakarta Indonesia
The Catholic University of Korea, Incheon St. Mary'S Hospital Incheon South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07730138 on ClinicalTrials.gov ↗ ← All trials in South Korea