Not yet recruiting NCT07730138
Phase 3 to Evaluate the Efficacy and Safety of DWP14012 in Patients With Gastric Ulcer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DWP14012 40mg (Fexuprazan), Lansoprazole 30mg.
- Who it may be relevant to
- Registry conditions: Gastric Ulcer. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia, South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
Interventions
- Drug DWP14012 40mg (Fexuprazan)
DWP14012 40mg(Fexuprazan) + placebo of Lansoprazole - Drug Lansoprazole 30mg
Lansoprazole 30mg + Placebo of DWP14012 40mg
Primary outcome measures
- Cumulative gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy through Week 8 [Time frame: Week 8]
Secondary outcome measures (7)
- Gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy at Week 4 [Time frame: Week 4]
- Gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy at Week 4 according to H. pylori infection status. [Time frame: Week 4]
- Cumulative gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy through Week 8 according to H. pylori infection status. [Time frame: Week 8]
- Changes in NDI scores at Weeks 4 and 8. [Time frame: Week 4 and Week 8]
- Changes in the number of gastric ulcers at Weeks 4 and 8. [Time frame: Week 4 and Week 8]
- Change from baseline in gastric ulcer size assessed by upper gastrointestinal endoscopy [Time frame: Week 4 and Week 8]
- Percentage change from baseline in gastric ulcer size assessed by upper gastrointestinal endoscopy at Week 4 and Week 8 [Time frame: Week 4 and Week 8]
Eligibility criteria
Inclusion criteria
- At least one gastric ulcer is present, and the largest gastric ulcer measures ≥ 3 mm and ≤ 30 mm in diameter
- The Sakita-Miwa classification of the largest gastric ulcer is A1 or A2.
Exclusion criteria
- Participants with a history of Zollinger-Ellison syndrome or conditions associated with gastric hypersecretion.
- 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.
- 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.
- 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
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Indonesia · 1 center
- RS Cipto Mangunkusumo — Jakarta
South Korea · 1 center
- The Catholic University of Korea, Incheon St. Mary'S Hospital — Incheon
Identifiers
NCT: NCT07730138 · DW_DWP14012315