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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
384
DWP14012 40mg(Fexuprazan) + placebo of Lansoprazole
Lansoprazole 30mg + Placebo of DWP14012 40mg
RS Cipto Mangunkusumo
Jakarta, Indonesia
The Catholic University of Korea, Incheon St. Mary'S Hospital
Incheon, South Korea
Cumulative gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy through Week 8
Time frame: Week 8
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.