About this trial
A Multi-center, Double-blind, Randomized, Active-controlled, Parallel-group, Phase III Clinical Trial and Open-label Extension Study to Evaluate the Efficacy and Safety of DWP14012 for Maintenance Therapy in Patients with Healed Erosive Esophagitis
Eligibility criteria
Qualifiers
Adult men and women aged 19 to 75 years at the time of written informed consent
Diagnosed with EE on an upper gastrointestinal endoscopy prior to the initiation of standard therapy
Healing of EE confirmed by upper gastrointestinal endoscopy performed prior to Visit 2 (Randomization), defined as the absence of mucosal breaks according to the LA Grade classification, after completion of standard therapy
Able to understand the information provided and complete the questionnaire
Disqualifiers
Presence of heartburn or acid regurgitation within 7 days prior to Visit 2 (Randomization)
On screening upper gastrointestinal endoscopy, presence of Barrett's esophagus (>3 cm), esophageal varices, esophageal stricture, ulcer-related stricture, active peptic ulcer, acute gastrointestinal bleeding, or malignancy
Patients with inflammatory bowel disease , irritable bowel syndrome, primary esophageal motility disorder, or pancreatitis
History of gastric acid secretion-inhibiting surgery or surgery on the stomach/esophagus (e.g., gastrectomy, endoscopic mucosal resection) or total small bowel resection
Trial design
Treatments tested in this trial
- DWP14012 20mg
- DWP14012 20 mg placebo
- DWC202517 15 mg
- DWC202517 15 mg placebo