Clinical Trials in South Korea / NCT07730138
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
Condition(s) studied
Gastric Ulcer
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| RS Cipto Mangunkusumo | Jakarta | Indonesia | |
| The Catholic University of Korea, Incheon St. Mary'S Hospital | Incheon | South Korea |
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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