Efficacy and Safety of DWP14012 for Long-Term Maintenance Therapy in Patients With Healed Erosive Esophagitis

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19-75
SponsorDaewoong Pharmaceutical Co. LTD.

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

Treatment groups

420 Participants
are divided into 4 treatment groups

Locations

This trial has no locations